Devices › Suture, absorbable, synthetic, polyglycolic acid
Device brand name · Suture absorbable synthetic polyglycolic ac
Biosyn: medical device reports filed with FDA
1,681 reports name it, 2012–2026. Manufacturer given most often on reports: Davis & Geck Caribe. Product code GAM.
- 1,681
- device reports naming the brand
- 0% of all MAUDE reports · about 116 a year
- 261
- reports, 12 months to August 2026
- 212 in the 12 months before
- 90.4%
- classified as malfunction
- 76.5% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 1,681 reports that name the brand "Biosyn" (suture absorbable synthetic polyglycolic ac), received between January 2012 and August 2026; the manufacturer given most often on reports is Davis & Geck Caribe. Spellings of one product vary from report to report.
261 reports arrived in the 12 months to August 2026, up 23% from 212 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 (90.4%) and injury (9.6%); across all suture, absorbable, synthetic, polyglycolic acid reports (product code GAM) death is recorded in 0.2% and malfunction in 76.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are detachment of device or device component (45.2%), break (41.4%) and unraveled material (5.9%). The patient problems coded most often are wound dehiscence, no patient involvement and post operative wound infection. 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
Who filed the report
Grey bar: all 56,946 reports carrying product code GAM. 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 |
|---|---|---|---|
| Detachment of device or device componentpart of the device came off | 760 | 45.2% | 16% |
| Breakthe device broke | 696 | 41.4% | 36.3% |
| Unraveled material | 99 | 5.9% | 1% |
| Patient-device incompatibilitythe device did not suit the patient | 85 | 5.1% | 1.1% |
| Mechanical problema mechanical problem | 40 | 2.4% | 0.2% |
| Material twisted/bent | 18 | 1.1% | 0.5% |
| Insufficient device problem information | 10 | 0.6% | 1.1% |
| Product quality problem | 9 | 0.5% | 0.5% |
| Manufacturing, packaging or shipping problem | 8 | 0.5% | 0.6% |
| Component missing | 7 | 0.4% | 0.6% |
| Material frayed | 7 | 0.4% | 1.2% |
| Detachment of device component | 5 | 0.3% | 1% |
| Dull, blunt | 5 | 0.3% | 0.3% |
| Difficult to open or remove packaging material | 4 | 0.2% | 0.2% |
| Bent | 3 | 0.2% | 0.2% |
| Device operates differently than expectedthe device behaved unexpectedly | 3 | 0.2% | 0.4% |
| Material integrity problema problem with the device material | 3 | 0.2% | 1.6% |
| Packaging problem | 3 | 0.2% | 0.3% |
| Device contamination with chemical or other material | 2 | 0.1% | 0% |
| Device slipped | 2 | 0.1% | 0.2% |
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.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Wound dehiscencea wound reopened | 88 | 5.2% |
| No patient involvement | 36 | 2.1% |
| Post operative wound infection | 28 | 1.7% |
| Granuloma | 22 | 1.3% |
| Skin inflammation/ irritation | 20 | 1.2% |
| Foreign body in patientpart of a device left in the patient | 17 | 1% |
| Unintended radiation exposure | 17 | 1% |
| Painpain, site not specified | 15 | 0.9% |
| Foreign body reaction | 14 | 0.8% |
| Itching sensation | 14 | 0.8% |
| Tissue breakdown | 14 | 0.8% |
| Tissue damage | 13 | 0.8% |
| Inflammationinflammation | 11 | 0.7% |
| Abscessa collection of pus | 10 | 0.6% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 8 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Biosyn | Product code GAM | All MAUDE reports |
|---|---|---|---|
| Reports | 1,681 | 56,946 | 26,136,888 |
| Share of that pool | — | 3% | 0% |
| Classified as death, per 1,000 reports | 0 | 2 | 9 |
| Classified as injury | 9.6% | 23% | 36.2% |
| Classified as malfunction | 90.4% | 76.5% | 62.3% |
| Filed by the manufacturer | 99.9% | 98% | 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 GAM
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Polysorb | 5,410 | 1,836 | 0% |
| V-Loc 180 | 3,447 | 678 | 0% |
| Vicryl Polyglactin 910 Suture Unknown Product | 2,373 | 210 | 1.2% |
| Coated VICRYL (polyglactin 910) Suture | 1,930 | 20 | 0.5% |
| Maxon | 1,809 | 309 | 0% |
| V-Loc 90 | 1,378 | 226 | 0% |
| VICRYL Polyglactin 910 Suture | 1,262 | 74 | 0.1% |
| Vcl+ Ud 27in 5-0 S/A Tf | 1,125 | 158 | 0.1% |
| Coated VICRYL | 978 | 851 | 0% |
| Vicryl Plus Antibacterial Polyglactin 910 Suture | 852 | 0 | 0.1% |
| Coated Vicryl Plus Antibacterial Polyglactin 910 | 724 | 0 | 0% |
| Vcl+ Ud 18in 5-0 S/A P-3 Prm Mp | 518 | 126 | 0% |
| Unknown VLoc Product | 413 | 39 | 3.6% |
| Caprosyn | 399 | 94 | 0% |
| Vcl+ Vio 36in 2-0 S/A Ct-1 | 399 | 42 | 0.3% |
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 Biosyn reports
How many FDA reports name Biosyn?
1,681 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 261 in the latest 12 months.
What kinds of events are reported?
malfunction (90.4%) and injury (9.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
detachment of device or device component (45.2%), break (41.4%), unraveled material (5.9%), patient-device incompatibility (5.1%) and mechanical problem (2.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%) and voluntary reports (0.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Biosyn 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.