Devices › Suture, surgical, absorbable, polydioxanone

Device brand name · Suture surgical absorbable polydioxanone

Sfx Spi Pds+ Bi Vio 14in2 Usp1 D/A Ctx: medical device reports filed with FDA

183 reports name it, 2023–2026. Manufacturer given most often on reports: Ethicon. Product code NEW.

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.

183
device reports naming the brand: 0% of all MAUDE reports · about 55 a year; 101
reports, 12 months to August 2026: 34 in the 12 months before; 99.5%
classified as malfunction: 76.8% across the product code; 0%
classified as death, as reported: 0 reports · not verified by FDA

183 medical device reports received by FDA name the brand "Sfx Spi Pds+ Bi Vio 14in2 Usp1 D/A Ctx" (suture surgical absorbable polydioxanone); the manufacturer given most often on reports is Ethicon; received from March 2023 to May 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

101 reports arrived in the 12 months to August 2026, up 197% from 34 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 (99.5%) and injury (0.5%); across all suture, surgical, absorbable, polydioxanone reports (product code NEW) death is recorded in 0.3% and malfunction in 76.8%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are material separation (68.9%), break (17.5%) and positioning failure (16.4%). The patient problems coded most often are foreign body in patient and pocket erosion. 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

Death0%0

Injury0.5%1

Malfunction99.5%182

Other0%0

Not given0%0

Who filed the report

Manufacturer report100%183

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given0%0

Grey bar: all 16,088 reports carrying product code NEW. 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
Material separation	126	68.9%	19.8%
Breakthe device broke	32	17.5%	50.7%
Positioning failure	30	16.4%	2.9%
Defective component	5	2.7%	0.6%
Material integrity problema problem with the device material	3	1.6%	2.4%

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
Foreign body in patientpart of a device left in the patient	1	0.5%
Pocket erosion	1	0.5%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

Measure	Sfx Spi Pds+ Bi Vio 14in2 Usp1 D/A Ctx	Product code NEW	All MAUDE reports
Reports	183	16,088	26,136,888
Share of that pool	—	1.1%	0%
Classified as death, per 1,000 reports	0	3	9
Classified as injury	0.5%	21.2%	36.2%
Classified as malfunction	99.5%	76.8%	62.3%
Filed by the manufacturer	100%	99.4%	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 NEW

Brand	Reports	Latest 12 months	Classified as death
Stratafix	925	647	0.1%
Sfx Sym Pds+ Uni Vio 18in 1 S/A Ct	427	0	0%
Sfx Sym Pds+ Uni Vio 18in 1 S/A Ctb-1	343	0	0%
Sfx Sym Pds+ Uni Vio 18in 1 S/A Ctx	308	0	0%
Sfx Sym Pds+ Uni Vio 18in 0 S/A Ct-1	302	0	0%
Stratafix Symmetric Pds Plus Knotless Tissue Control Device	270	0	0%
Sfxspi Pds+ Bi Vio 14in2 1 Da Ctx	260	0	0%
Sfx Sym Pds+ Uni Vio 18in 1 S/A Ct-1	220	0	0.5%
Sfx Sym Pds+ Uni Vio 18in 0 S/A Ct	207	0	0%
Pds	211	199	0%
Stratafix Unknown	198	15	0.5%
Stratafix Knotless Tissue Control Device	225	0	0.4%
Pds Plus Antibacterial Polydioxanone Suture	156	0	0%
Suture Unknown	469	39	0.6%
Absorbable Surgical Suture Usp	361	27	0%

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 Sfx Spi Pds+ Bi Vio 14in2 Usp1 D/A Ctx reports

How many FDA reports name Sfx Spi Pds+ Bi Vio 14in2 Usp1 D/A Ctx?

183 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 101 in the latest 12 months.

What kinds of events are reported?

malfunction (99.5%) and injury (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

material separation (68.9%), break (17.5%), positioning failure (16.4%), defective component (2.7%) and material integrity problem (1.6%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Sfx Spi Pds+ Bi Vio 14in2 Usp1 D/A Ctx 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.