Suture, absorbable, synthetic, polyglycolic acid: medical device reports filed with FDA

56,946 reports carry this product code, 1994–2026; 30 brands with a page.

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.

56,946
reports with this product code: 0.2% of all MAUDE reports; 9,309
reports, 12 months to August 2026: 8,262 in the 12 months before; 76.5%
classified as malfunction: 62.3% across all reports; 0.2%
classified as death, as reported: 0.9% across all reports

Product code GAM is FDA's classification for "Suture, absorbable, synthetic, polyglycolic acid" (general, Plastic Surgery panel), a class 2 device. 56,946 medical device reports carry this product code, 0.2% of the MAUDE database, from June 1994 to August 2026.

9,309 reports arrived in the 12 months to August 2026, up 13% from 8,262 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 (76.5%), injury (23%) and other (0.2%). 30 brand names 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
Polysorb	5,180	1,836	0%	86%
V-Loc 180	3,446	678	0%	86.1%
Vicryl Polyglactin 910 Suture Unknown Product	2,373	210	1.2%	6.5%
Coated VICRYL (polyglactin 910) Suture	1,896	20	0.5%	19.4%
Maxon	1,806	309	0%	93.9%
Biosyn	1,681	261	0%	90.4%
V-Loc 90	1,378	226	0%	95.3%
VICRYL Polyglactin 910 Suture	1,259	74	0.1%	30.9%
Vcl+ Ud 27in 5-0 S/A Tf	1,125	158	0.1%	98.7%
Coated VICRYL	976	851	0%	92.4%
Vicryl Plus Antibacterial Polyglactin 910 Suture	852	0	0.1%	67.6%
Coated Vicryl Plus Antibacterial Polyglactin 910	722	0	0%	83.4%
Vcl+ Ud 18in 5-0 S/A P-3 Prm Mp	518	126	0%	99%
Unknown VLoc Product	406	39	3.6%	12.6%
Caprosyn	399	94	0%	93.7%
Vcl+ Vio 36in 2-0 S/A Ct-1	399	42	0.3%	86.2%
Absorbable Surgical Suture Usp	357	27	0%	91.1%
Vcl+ Vio 36in 1 S/A Ct	313	26	0.3%	93.3%
Vcl+ Vio 36in 0 S/A Ct	308	22	0%	96.4%
Panacryl L-Lactide/Glycolide Suture	306	0	0%	0%
Vcl+ Vio 27in 3-0 S/A Sh-1	274	17	0%	93.4%
Unknown Suture Product	266	28	0.9%	45.3%
Vicryl Plus Polyglactin 910 Suture Unknown Prod	259	5	1.2%	10%
Monocryl Plus Suture	244	6	0%	83.6%
Vcl+ Ud 27in 5-0 S/A Rb-1	244	41	0%	100%
Vcl Ct Brd Ud 27in 5-0 S/A Tf	231	17	0%	100%
VICRYL Rapide Polyglactin 910 Suture	223	35	0%	35%
Vcl Ct Brd Vio 18in 6-0 D/A S-14	214	40	0%	90.7%
Stratafix	204	647	0.1%	74.8%
VICRYL Plus Polyglactin 910 Suture	203	87	0%	56.7%

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	33,508	58.8%
Davis & Geck Caribe	6,401	11.2%
Covidien North Haven	5,674	10%
B Braun Surgical	4,617	8.1%
Covidien Surgical	2,654	4.7%
Ethicon San Angelo	941	1.7%
United States Surgical	594	1%
Covidien Formerly US Surgical A Divison	384	0.7%
Covidien Formerly US Surgical	128	0.2%
North Haven - Uss	118	0.2%
Depuy Mitek	22	0%
Ponce - Uss	9	0%
Sofradim Production Sas	6	0%
US Surgical Puerto Rico	6	0%
Aesculap	5	0%

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

Death0.2%88

Injury23%13,121

Malfunction76.5%43,573

Other0.2%94

Not given0.1%70

Who filed

Manufacturer report98%55,783

Voluntary report1.1%629

User facility report0%0

Distributor report0%2

Not given0.9%532

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	20,647	36.3%
Material separation	10,680	18.8%
Detachment of device or device componentpart of the device came off	9,110	16%
Other (for use when an appropriate device code cannot be identified)	1,495	2.6%
Needle, separation	955	1.7%
Material integrity problema problem with the device material	925	1.6%
Material frayed	700	1.2%
Insufficient device problem information	642	1.1%
Patient-device incompatibilitythe device did not suit the patient	634	1.1%
Reactiona reaction, type not specified	612	1.1%
Detachment of device component	555	1%
Unraveled material	554	1%
Material split, cut or torn	394	0.7%
Failure to adhere or bond	388	0.7%
Suture line disruption	388	0.7%
Device markings/labelling problema problem with the device markings or label	347	0.6%
Explanted	339	0.6%
Component missing	337	0.6%
Manufacturing, packaging or shipping problem	330	0.6%
Product quality problem	298	0.5%

Questions about suture, absorbable, synthetic, polyglycolic acid reports

What is product code GAM?

FDA's classification code for "Suture, absorbable, synthetic, polyglycolic acid", 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?

56,946 reports through August 2026, 9,309 of them in the latest 12 months.

Which brands appear most often?

Polysorb (5,180), V-Loc 180 (3,446), Vicryl Polyglactin 910 Suture Unknown Product (2,373), Coated VICRYL (polyglactin 910) Suture (1,896) and Maxon (1,806). 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.