Devices › Fastener, fixation, biodegradable, soft tissue
Device brand name · Fastener fixation biodegradable soft tissue
Healix Advance Orthocord: medical device reports filed with FDA
188 reports name it, 2026–2026. Manufacturer given most often on reports: Depuy Mitek US. Product code MAI.
- 188
- device reports naming the brand
- 0% of all MAUDE reports · about 188 a year
- 188
- reports, 12 months to August 2026
- 0 in the 12 months before
- 99.5%
- classified as malfunction
- 73.8% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
188 medical device reports received by FDA name the brand "Healix Advance Orthocord" (fastener fixation biodegradable soft tissue); the manufacturer given most often on reports is Depuy Mitek US; received from February 2026 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
188 reports arrived in the 12 months to August 2026, with 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 (99.5%) and injury (0.5%); 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 break (87.8%), migration (7.4%) and crack (2.7%). 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.
Event type and report source
Event type, as classified on the report
Who filed the report
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 |
|---|---|---|---|
| Breakthe device broke | 165 | 87.8% | 56.6% |
| Migrationthe device moved from where it was placed | 14 | 7.4% | 2.6% |
| Crackthe device cracked | 5 | 2.7% | 2.7% |
| Device damaged prior to receipt by user | 4 | 2.1% | 0% |
| Difficult to advance | 3 | 1.6% | 1.2% |
| Detachment of device or device componentpart of the device came off | 1 | 0.5% | 2.3% |
| Material deformation | 1 | 0.5% | 2.2% |
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 | Healix Advance Orthocord | Product code MAI | All MAUDE reports |
|---|---|---|---|
| Reports | 188 | 17,237 | 26,136,888 |
| Share of that pool | — | 1.1% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 0.5% | 23.9% | 36.2% |
| Classified as malfunction | 99.5% | 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% |
| Healicoil Knotless Rgnst | 330 | 108 | 0% |
| PEEK SWIVELOCK C,4.75x19.1MM | 167 | 58 | 0% |
| 5 5 Healix Advance Kntlss Br | 156 | 25 | 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 Healix Advance Orthocord reports
How many FDA reports name Healix Advance Orthocord?
188 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 188 in the latest 12 months.
What kinds of events are reported?
malfunction (99.5%) and injury (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (87.8%), migration (7.4%), crack (2.7%), device damaged prior to receipt by user (2.1%) and difficult to advance (1.6%). 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 Healix Advance Orthocord 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.