Reported Reactions

Devices › Mesh, surgical

Device brand name · Surgical mesh

Veritas Collagen Matrix: medical device reports filed with FDA

206 reports name it, 2007–2014. Manufacturer given most often on reports: Synovis Surgical Innovations. Product code FTM.

206
device reports naming the brand
0% of all MAUDE reports · about 11 a year
0
reports, 12 months to August 2026
0 in the 12 months before
1.9%
classified as malfunction
5.2% across the product code
0.5%
classified as death, as reported
1 reports · not verified by FDA

FDA's MAUDE database holds 206 reports that name the brand "Veritas Collagen Matrix" (surgical mesh), received between October 2007 and November 2014; the manufacturer given most often on reports is Synovis Surgical Innovations. Spellings of one product vary from report to report.

0 reports arrived in the 12 months to August 2026, and none 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 injury (94.7%), other (2.9%) and malfunction (1.9%); across all mesh, surgical reports (product code FTM) death is recorded in 0.4% and malfunction in 5.2%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are insufficient device problem information (35%), device operates differently than expected (6.8%) and torn material (6.3%). The patient problems coded most often are hernia, seroma 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

No report naming Veritas Collagen Matrix was received in the five years to August 2026; the latest was received in November 2014.

By year received

027532007: 420072008: 2220082009: 1320092010: 2920102011: 5320112012: 5220122013: 1220132014: 212014

Event type and report source

Event type, as classified on the report

Death0.5%1
Injury94.7%195
Malfunction1.9%4
Other2.9%6
Not given0%0

Who filed the report

Manufacturer report99%204
Voluntary report1%2
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 11,623 reports carrying product code FTM. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Insufficient device problem information7235%36.3%
Device operates differently than expectedthe device behaved unexpectedly146.8%1.7%
Torn material136.3%0.8%
Material disintegration94.4%0.9%
Device dislodged or dislocated62.9%0.2%
Device remains implanted62.9%0.5%
Tears, rips, holes in device, device material62.9%0.3%
Migration or expulsion of device52.4%2.6%
Loose41.9%0%
Material deformation41.9%0.5%
Material separation41.9%0.1%
Patient-device incompatibilitythe device did not suit the patient41.9%2.2%
Replace41.9%0.3%
Stretched41.9%0%
Breakthe device broke31.5%1%
Degraded31.5%0.6%
Device or device fragments location unknown31.5%0.2%
Device slipped31.5%0.2%
Device, removal of (non-implant)31.5%0%
Dislodged31.5%0%

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)ReportsShare
Hernia4320.9%
Seromaa collection of fluid under the skin3617.5%
Post operative wound infection167.8%
Erythemaskin redness146.8%
Painpain, site not specified146.8%
Bacterial infectiona bacterial infection136.3%
Abscessa collection of pus83.9%
Adhesion(s)83.9%
Surgical procedure, additional83.9%
Therapy/non-surgical treatment, additional83.9%
Tissue damage83.9%
Inflammationinflammation73.4%
Therapeutic response, decreased73.4%
Failure of implant62.9%
Reactiona reaction, type not specified62.9%

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

In context

MeasureVeritas Collagen MatrixProduct code FTMAll MAUDE reports
Reports20611,62326,136,888
Share of that pool—1.8%0%
Classified as death, per 1,000 reports549
Classified as injury94.7%87.1%36.2%
Classified as malfunction1.9%5.2%62.3%
Filed by the manufacturer99%96.2%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 FTM

BrandReportsLatest 12 monthsClassified as death
Unspecified By Complainant2,00500%
Gynecare Mesh Unknown5,83030.1%
Pelvisoft Acellular Collagen Biomesh1,01600%
Xenform78100%
Strattice32001.9%
Unknown Strattice295470.7%
Mesh Tsl - Permacol30542.6%
XenMatrix27880.7%
Permacol38010.5%
Unk - Unspecified By The Complainant27200%
Orthadapt Bioimplant19700%
Biodesign 4-Layer Tissue Graft20400%
Unknown - Unspecified By The Complainant24100%
Uphold Vaginal Support System1,86100.1%
Unspecified By The Complainant54500%

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 Veritas Collagen Matrix reports

How many FDA reports name Veritas Collagen Matrix?

206 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

injury (94.7%), other (2.9%) and malfunction (1.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

insufficient device problem information (35%), device operates differently than expected (6.8%), torn material (6.3%), material disintegration (4.4%) and device dislodged or dislocated (2.9%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (99%) and voluntary reports (1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Veritas Collagen Matrix 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.