Device brand name · Lrk - device anti-snoring

Implant Pds3000m 6pk Pillar Palatal: medical device reports filed with FDA

325 reports name it, 2012–2013. Manufacturer given most often on reports: Medtronic Xomed. Product code LRK.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

325
device reports naming the brand: 0% of all MAUDE reports · about 23 a year; 0
reports, 12 months to August 2026: 0 in the 12 months before; 32%
classified as malfunction: 72.5% across the product code; 0%
classified as death, as reported: 0 reports · not verified by FDA

FDA's MAUDE database holds 325 reports that name the brand "Implant Pds3000m 6pk Pillar Palatal" (lrk - device anti-snoring), received between February 2012 and December 2013; the manufacturer given most often on reports is Medtronic Xomed. Spellings of one product vary from report to report.

0 reports arrived in the 12 months to August 2026, and none in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (67.4%) and malfunction (32%); across all device, anti-snoring reports (product code LRK) death is recorded in 0% and malfunction in 72.5%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are extrusion (54.5%), migration or expulsion of device (49.2%) and unintended movement (3.4%). The patient problems coded most often are local reaction, dysphagia/ odynophagia and pain. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Reports by month, five years

No report naming Implant Pds3000m 6pk Pillar Palatal was received in the five years to August 2026; the latest was received in December 2013.

Event type and report source

Event type, as classified on the report

Death0%0

Injury67.4%219

Malfunction32%104

Other0%0

Not given0.6%2

Who filed the report

Manufacturer report100%325

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given0%0

Grey bar: all 2,783 reports carrying product code LRK. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)	Reports	Share	Share across product code
Extrusion	177	54.5%	8.8%
Migration or expulsion of device	160	49.2%	7.5%
Unintended movement	11	3.4%	0.4%
Expulsion	6	1.8%	0.2%
Insufficient device problem information	6	1.8%	2.8%
Device operates differently than expectedthe device behaved unexpectedly	3	0.9%	0.5%
Material protrusion/extrusion	3	0.9%	0.2%
Unintended ejection	2	0.6%	0.1%
Activation, positioning or separation problem	1	0.3%	0%
Aspiration issue	1	0.3%	0%
Malposition of device	1	0.3%	0.3%
Patient-device incompatibilitythe device did not suit the patient	1	0.3%	1.1%
Positioning failure	1	0.3%	0.1%
Positioning problem	1	0.3%	0%

FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.

Patient problems coded

Patient problem (FDA code)	Reports	Share
Local reaction	142	43.7%
Dysphagia/ odynophagia	70	21.5%
Painpain, site not specified	55	16.9%
Erosion	52	16%
Foreign body sensation in eye	32	9.8%
Failure of implant	5	1.5%
Perforation	5	1.5%
Discomfortdiscomfort	3	0.9%
Foreign body in patientpart of a device left in the patient	2	0.6%
Sore throat	2	0.6%
Aspiration/inhalation	1	0.3%
Bacterial infectiona bacterial infection	1	0.3%
Chokingchoking	1	0.3%
Dysphasia	1	0.3%
Skin irritationirritated skin	1	0.3%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

Measure	Implant Pds3000m 6pk Pillar Palatal	Product code LRK	All MAUDE reports
Reports	325	2,783	26,136,888
Share of that pool	—	11.7%	0%
Classified as death, per 1,000 reports	0	0	9
Classified as injury	67.4%	26.7%	36.2%
Classified as malfunction	32%	72.5%	62.3%
Filed by the manufacturer	100%	96.4%	94.9%

Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Other brands with product code LRK

Brand	Reports	Latest 12 months	Classified as death
Silent Nite	583	480	0%
Silent Nite 3D One Piece	294	285	0%
EndSnorZ Sleep Appliance (Silent Nite 3D)	154	115	0%

Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."

Questions about Implant Pds3000m 6pk Pillar Palatal reports

How many FDA reports name Implant Pds3000m 6pk Pillar Palatal?

325 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

injury (67.4%) and malfunction (32%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

extrusion (54.5%), migration or expulsion of device (49.2%), unintended movement (3.4%), expulsion (1.8%) and insufficient device problem information (1.8%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Implant Pds3000m 6pk Pillar Palatal was at fault?

No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."

How do I report a problem with a medical device?

Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.