Artelon Cmc Spacer: medical device reports filed with FDA

182 reports name it, 2007–2013. Manufacturer given most often on reports: Artimplant. Product code KYI.

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.

182
device reports naming the brand: 0% of all MAUDE reports · about 9 a year; 0
reports, 12 months to August 2026: 0 in the 12 months before; 0%
classified as malfunction: 2.3% across the product code; 0%
classified as death, as reported: 0 reports · not verified by FDA

FDA's MAUDE database holds 182 reports that name the brand "Artelon Cmc Spacer" (spacer), received between February 2007 and August 2013; the manufacturer given most often on reports is Artimplant. 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 (98.9%) and other (1.1%); across all prosthesis, wrist, carpal trapezium reports (product code KYI) death is recorded in 0% and malfunction in 2.3%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are implant, removal of (53.8%), explanted (20.9%) and insufficient device problem information (14.3%). The patient problems coded most often are arthralgia, injury 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 Artelon Cmc Spacer was received in the five years to August 2026; the latest was received in August 2013.

By year received

Event type and report source

Event type, as classified on the report

Death0%0

Injury98.9%180

Malfunction0%0

Other1.1%2

Not given0%0

Who filed the report

Manufacturer report98.4%179

Voluntary report1.6%3

User facility report0%0

Distributor report0%0

Not given0%0

Grey bar: all 345 reports carrying product code KYI. 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
Implant, removal of	98	53.8%	34.2%
Explanted	38	20.9%	19.4%
Insufficient device problem information	26	14.3%	19.7%
Device remains implanted	4	2.2%	2.3%
Patient-device incompatibilitythe device did not suit the patient	2	1.1%	0.9%
Device operates differently than expectedthe device behaved unexpectedly	1	0.5%	1.2%
Device slipped	1	0.5%	3.5%

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
Arthralgiajoint pain	47	25.8%
Injurya physical injury	27	14.8%
Painpain, site not specified	24	13.2%
Surgical procedure	19	10.4%
Joint swellinga swollen joint	13	7.1%
Inflammationinflammation	12	6.6%
Osteolysis	10	5.5%
Failure of implant	9	4.9%
Foreign body reaction	7	3.8%
Swellingswelling	6	3.3%
Irritationirritation	5	2.7%
Reactiona reaction, type not specified	3	1.6%
Surgical procedure, repeated	3	1.6%
Arthritis	2	1.1%
Edemaswelling from fluid	2	1.1%

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

In context

Measure	Artelon Cmc Spacer	Product code KYI	All MAUDE reports
Reports	182	345	26,136,888
Share of that pool	—	52.8%	0%
Classified as death, per 1,000 reports	0	0	9
Classified as injury	98.9%	94.8%	36.2%
Classified as malfunction	0%	2.3%	62.3%
Filed by the manufacturer	98.4%	93.6%	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."

Questions about Artelon Cmc Spacer reports

How many FDA reports name Artelon Cmc Spacer?

182 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 (98.9%) and other (1.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

implant, removal of (53.8%), explanted (20.9%), insufficient device problem information (14.3%), device remains implanted (2.2%) and patient-device incompatibility (1.1%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (98.4%) and voluntary reports (1.6%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Artelon Cmc Spacer 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.