Suture, surgical, absorbable, polydioxanone: medical device reports filed with FDA

16,088 reports carry this product code, 2006–2026; 18 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.

16,088
reports with this product code: 0.1% of all MAUDE reports; 2,382
reports, 12 months to August 2026: 2,519 in the 12 months before; 76.8%
classified as malfunction: 62.3% across all reports; 0.3%
classified as death, as reported: 0.9% across all reports

Product code NEW is FDA's classification for "Suture, surgical, absorbable, polydioxanone" (general, Plastic Surgery panel), a class 2 device. 16,088 medical device reports carry this product code, 0.1% of the MAUDE database, from December 2006 to August 2026.

2,382 reports arrived in the 12 months to August 2026, close to the 2,519 of 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 (76.8%), injury (21.2%) and other (1.5%). 18 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
Stratafix	675	647	0.1%	74.8%
Sfx Sym Pds+ Uni Vio 18in 1 S/A Ct	427	0	0%	94.8%
Sfx Sym Pds+ Uni Vio 18in 1 S/A Ctb-1	343	0	0%	87.5%
Sfx Sym Pds+ Uni Vio 18in 1 S/A Ctx	308	0	0%	85.4%
Sfx Sym Pds+ Uni Vio 18in 0 S/A Ct-1	302	0	0%	88.7%
Stratafix Symmetric Pds Plus Knotless Tissue Control Device	270	0	0%	54.1%
Sfxspi Pds+ Bi Vio 14in2 1 Da Ctx	260	0	0%	99.6%
Sfx Sym Pds+ Uni Vio 18in 1 S/A Ct-1	220	0	0.5%	87.3%
Sfx Sym Pds+ Uni Vio 18in 0 S/A Ct	207	0	0%	97.1%
Pds	206	199	0%	87.2%
Stratafix Unknown	198	15	0.5%	33.3%
Stratafix Knotless Tissue Control Device	196	0	0.4%	27.6%
Sfx Spi Pds+ Bi Vio 14in2 Usp1 D/A Ctx	183	101	0%	99.5%
Pds Plus Antibacterial Polydioxanone Suture	153	0	0%	68.6%
Suture Unknown	12	39	0.6%	50.1%
Absorbable Surgical Suture Usp	4	27	0%	91.1%
Depuy	1	9	1.8%	27.9%
Omnispan Meniscal Repair System/27 Degree	1	0	0%	95.5%

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	14,662	91.1%
B Braun Surgical	435	2.7%
Medos International S Rl	7	0%
Medos International Sarl	6	0%
Aesculap	2	0%
Depuy Mitek	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

Death0.3%41

Injury21.2%3,404

Malfunction76.8%12,362

Other1.5%247

Not given0.2%34

Who filed

Manufacturer report99.4%15,988

Voluntary report0.3%48

User facility report0%0

Distributor report0%0

Not given0.3%52

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

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	8,164	50.7%
Material separation	3,191	19.8%
Positioning failure	464	2.9%
Material integrity problema problem with the device material	392	2.4%
Detachment of device or device componentpart of the device came off	217	1.3%
Detachment of device component	189	1.2%
Insufficient device problem information	160	1%
Material frayed	131	0.8%
Other (for use when an appropriate device code cannot be identified)	123	0.8%
Patient device interaction problem	122	0.8%
Failure to adhere or bond	110	0.7%
Defective component	104	0.6%
Needle, separation	97	0.6%
Device markings/labelling problema problem with the device markings or label	78	0.5%
Tear, rip or hole in device packaging	72	0.4%
Migrationthe device moved from where it was placed	71	0.4%
Delivered as unsterile product	68	0.4%
Device operates differently than expectedthe device behaved unexpectedly	62	0.4%
Positioning problem	59	0.4%
Component misassembled	54	0.3%

Questions about suture, surgical, absorbable, polydioxanone reports

What is product code NEW?

FDA's classification code for "Suture, surgical, absorbable, polydioxanone", 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?

16,088 reports through August 2026, 2,382 of them in the latest 12 months.

Which brands appear most often?

Stratafix (675), Sfx Sym Pds+ Uni Vio 18in 1 S/A Ct (427), Sfx Sym Pds+ Uni Vio 18in 1 S/A Ctb-1 (343), Sfx Sym Pds+ Uni Vio 18in 1 S/A Ctx (308) and Sfx Sym Pds+ Uni Vio 18in 0 S/A Ct-1 (302). 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.