Devices › Device types
FDA product code OXC · class 2 · General, Plastic Surgery
Mesh, surgical, absorbable, staple line reinforcement: medical device reports filed with FDA
352 reports carry this product code, 2018–2026; 1 brands with a page.
- 352
- reports with this product code
- 0% of all MAUDE reports
- 68
- reports, 12 months to August 2026
- 19 in the 12 months before
- 72.7%
- classified as malfunction
- 62.3% across all reports
- 0.3%
- classified as death, as reported
- 0.9% across all reports
Product code OXC is FDA's classification for "Mesh, surgical, absorbable, staple line reinforcement" (general, Plastic Surgery panel), a class 2 device. 352 medical device reports carry this product code, 0% of the MAUDE database, from June 2018 to August 2026.
68 reports arrived in the 12 months to August 2026, up 258% from 19 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 (72.7%), injury (27%) and death (0.3%). 1 brand name with a page on this site carry this code; the brands table is 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."
Brands with this product code
| Brand | Reports | Latest 12 months | Classified as death | Classified as malfunction |
|---|---|---|---|---|
| Echelon 60mm Reinforcement | 298 | 25 | 0.3% | 75% |
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."
Manufacturers named
| Manufacturer (as written on reports) | Reports | Share |
|---|---|---|
| Ethicon Endo-Surgery | 327 | 92.9% |
Reports by month, five years
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
Who filed
Grey bar: all 26,136,888 MAUDE reports.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Ambient temperature problem | 198 | 56.3% |
| Failure to form staple | 26 | 7.4% |
| Material integrity problema problem with the device material | 23 | 6.5% |
| Mechanical problema mechanical problem | 9 | 2.6% |
| Failure to fire | 5 | 1.4% |
| Difficult to insertthe device was hard to insert | 4 | 1.1% |
| Patient device interaction problem | 4 | 1.1% |
| Delivered as unsterile product | 3 | 0.9% |
| Failure to cut | 3 | 0.9% |
| Insufficient device problem information | 3 | 0.9% |
| Device appears to trigger rejection | 2 | 0.6% |
| Difficult to open or remove packaging material | 2 | 0.6% |
| Firing problem | 2 | 0.6% |
| Patient-device incompatibilitythe device did not suit the patient | 2 | 0.6% |
| Component or accessory incompatibility | 1 | 0.3% |
| Contamination /decontamination problem | 1 | 0.3% |
| Device contamination with chemical or other material | 1 | 0.3% |
| Device slipped | 1 | 0.3% |
| Leak/splashthe device leaked | 1 | 0.3% |
| Material split, cut or torn | 1 | 0.3% |
Questions about mesh, surgical, absorbable, staple line reinforcement reports
What is product code OXC?
FDA's classification code for "Mesh, surgical, absorbable, staple line reinforcement", class 2, reviewed by the general, Plastic Surgery panel. Every device report carries the product code of the device involved.
How many reports carry this code?
352 reports through August 2026, 68 of them in the latest 12 months.
Which brands appear most often?
Echelon 60mm Reinforcement (298). Widely used products collect more reports because more people use them.
Can the brands table be used to rank the devices?
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." Brands differ in how many are in use, how long they have been sold and how reports are collected.
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. 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.