Suture, nonabsorbable, silk: medical device reports filed with FDA

4,019 reports carry this product code, 1992–2026; 8 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.

4,019
reports with this product code: 0% of all MAUDE reports; 550
reports, 12 months to August 2026: 440 in the 12 months before; 80.1%
classified as malfunction: 62.3% across all reports; 0.2%
classified as death, as reported: 0.9% across all reports

Product code GAP is FDA's classification for "Suture, nonabsorbable, silk" (general, Plastic Surgery panel), a class 2 device. 4,019 medical device reports carry this product code, 0% of the MAUDE database, from December 1992 to August 2026.

550 reports arrived in the 12 months to August 2026, up 25% from 440 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 (80.1%), injury (19.5%) and death (0.2%). 8 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
Silk Suture Unknown Product	548	32	1.3%	49.1%
Silk Brd Blk 15x60cm M2 5	363	44	0%	77.4%
Sofsilk	317	49	0%	91%
Silk Brd Blk 15x60cm M2 0	248	29	0%	72.6%
Silk Suture	155	35	0%	69.8%
Non Absorbable Surgical Suture	52	39	0%	96.4%
ETHILON Nylon Suture	2	9	0.2%	47.6%
Ethicon	1	164	2.3%	54.2%

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	3,084	76.7%
B Braun Surgical	248	6.2%
Davis & Geck Caribe	194	4.8%
United States Surgical	94	2.3%
Alcon Research - Alcon Precision Device	11	0.3%
Arthrocare	3	0.1%
Covidien North Haven	3	0.1%
Covidien Valleylab	1	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%8

Injury19.5%782

Malfunction80.1%3,220

Other0.1%5

Not given0.1%4

Who filed

Manufacturer report98.3%3,952

Voluntary report0.8%31

User facility report0%0

Distributor report0%0

Not given0.9%36

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

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	2,134	53.1%
Material separation	399	9.9%
Detachment of device or device componentpart of the device came off	173	4.3%
Material split, cut or torn	105	2.6%
Device contaminated during manufacture or shipping	97	2.4%
Suture line disruption	77	1.9%
Detachment of device component	49	1.2%
Delivered as unsterile product	47	1.2%
Manufacturing, packaging or shipping problem	44	1.1%
Component misassembled	38	0.9%
Material frayed	33	0.8%
Product quality problem	33	0.8%
Material integrity problema problem with the device material	28	0.7%
Device markings/labelling problema problem with the device markings or label	27	0.7%
Packaging problem	24	0.6%
Biocompatibility	17	0.4%
Defective component	17	0.4%
Insufficient device problem information	16	0.4%
Nonstandard device	16	0.4%
Reactiona reaction, type not specified	16	0.4%

Questions about suture, nonabsorbable, silk reports

What is product code GAP?

FDA's classification code for "Suture, nonabsorbable, silk", 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?

4,019 reports through August 2026, 550 of them in the latest 12 months.

Which brands appear most often?

Silk Suture Unknown Product (548), Silk Brd Blk 15x60cm M2 5 (363), Sofsilk (317), Silk Brd Blk 15x60cm M2 0 (248) and Silk Suture (155). 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.