Omnispan Meniscal Repair System/27 Degree: medical device reports filed with FDA

155 reports name it, 2015–2023. Manufacturer given most often on reports: Depuy Mitek US. Product code MAI.

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.

155
device reports naming the brand: 0% of all MAUDE reports · about 14 a year; 0
reports, 12 months to August 2026: 0 in the 12 months before; 95.5%
classified as malfunction: 73.8% across the product code; 0%
classified as death, as reported: 0 reports · not verified by FDA

155 medical device reports received by FDA name the brand "Omnispan Meniscal Repair System/27 Degree" (soft-tissue anchor bioabsorbable); the manufacturer given most often on reports is Depuy Mitek US; received from May 2015 to August 2023. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

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 malfunction (95.5%) and injury (4.5%); across all fastener, fixation, biodegradable, soft tissue reports (product code MAI) death is recorded in 0% and malfunction in 73.8%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are device-device incompatibility (69.7%), break (17.4%) and detachment of device or device component (3.9%). 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

Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

By year received

Event type and report source

Event type, as classified on the report

Death0%0

Injury4.5%7

Malfunction95.5%148

Other0%0

Not given0%0

Who filed the report

Manufacturer report100%155

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given0%0

Grey bar: all 17,237 reports carrying product code MAI. 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
Device-device incompatibility	108	69.7%	3.1%
Breakthe device broke	27	17.4%	56.6%
Detachment of device or device componentpart of the device came off	6	3.9%	2.3%
Material deformation	2	1.3%	2.2%
Migrationthe device moved from where it was placed	2	1.3%	2.6%
Physical resistance/sticking	2	1.3%	0.4%
Crackthe device cracked	1	0.6%	2.7%
Delivered as unsterile product	1	0.6%	0.1%
Difficult to advance	1	0.6%	1.2%
Mechanical jam	1	0.6%	0.6%
Packaging problem	1	0.6%	0.1%

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.

In context

Measure	Omnispan Meniscal Repair System/27 Degree	Product code MAI	All MAUDE reports
Reports	155	17,237	26,136,888
Share of that pool	—	0.9%	0%
Classified as death, per 1,000 reports	0	0	9
Classified as injury	4.5%	23.9%	36.2%
Classified as malfunction	95.5%	73.8%	62.3%
Filed by the manufacturer	100%	98.6%	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."

Other brands with product code MAI

Brand	Reports	Latest 12 months	Classified as death
Gryphon P Br Ds Anchor W/Oc	554	111	0%
4 5 Healix Advance Br W/Ocord	488	140	0%
4 75 Healix Advance Kntlss Br	493	71	0%
UNK - Implant	771	80	0%
Omnispan Meniscal Repair 27deg	714	161	0%
Bio-Comp Swvlk C Cld 4 75x19 1mm	361	119	0%
Omnispan Meniscal Repair 12deg	438	44	0%
Twinfix Ultra Ha 4 5 W/2 Ub Wh & Blue	316	56	0%
4 5 Healix Advance Br3sut W/Oc	238	12	0%
Osteoraptor 2 9 W/ 2 Ub White / Blue	290	55	0%
Lupine Br Ds W/Orthcrd	292	44	0%
Bio-Compsi Crkscrw Ft 4 5x 14mm	209	88	0%
Healix Advance Orthocord	188	188	0%
Healicoil Knotless Rgnst	330	108	0%
PEEK SWIVELOCK C,4.75x19.1MM	167	58	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 Omnispan Meniscal Repair System/27 Degree reports

How many FDA reports name Omnispan Meniscal Repair System/27 Degree?

155 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?

malfunction (95.5%) and injury (4.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

device-device incompatibility (69.7%), break (17.4%), detachment of device or device component (3.9%), material deformation (1.3%) and migration (1.3%). 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 Omnispan Meniscal Repair System/27 Degree 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.