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OviTex® PRS R20243-1122PRecalls & reported problems

Tela Bio, Inc. · The OviTex® PRS Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of non-dermal sourced layers of extracellular matrix (ECM) (ovine (sheep) derived ECM), paired with a minimal suture footprint. The OviTex PRS Reinforced Tissue Matrix Device provides an alternative device solution to permanent synthetic, resorbable/bioabsorbable synthetic, and biologic meshes. The device is permeable to facilitate fluid management, provides controlled stretch, and will incorporate into recipient tissue with associated cellular and microvascular ingrowth. Reinforced tissue matrices remodel into host tissue while maintaining compatibility with the body. The OviTex PRS Reinforced Tissue Matrix Device is for use in plastic and reconstructive surgery. · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00856072005142), received between Aug 25, 2023 and Aug 25, 2023 — classified as 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Fluid Discharge1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A SURGEON REPORTED THAT AFTER A BILATERAL PREPECTORAL SINGLE STAGE BREAST RECONSTRUCTION WITH OVITEX PRS PP AND ADM (ACELLULAR DERMAL MATRIX) THAT OVITEX PRS EXTRUDED OUT OF THE INCISION 3 WEEKS POST-OP (WITH DRAINS REMOVED 8 DAYS POST OP). THE DEVICES ON THIS SIDE WERE REPLACED WITH AN ADM. A REVIEW OF THE SURGEON'S POST SUGGESTS THE FOLLOWING CLINICAL COURSE. BILATERAL DIRECT TO IMPLANT BREAST RECONSTRUCTION WAS PERFORMED WITH 600CC BREAST IMPLANTS AND OVITEX PRS USED IN THE LOWER POLE AND ADM IN THE UPPER. DRAINS WERE PULLED APPROXIMATELY 8 DAYS AFTER SURGERY WHEN 20CC/DAY OF FLUID WAS REMOVED. FLUID BEGAN NECESSITATING OUT OF THE WOUND ON ONE SIDE APPROXIMATELY 2 WEEKS LATER. THE SURGEON REMOVED THE MATERIAL AND REPLACED WITH AN ADM. IT IS UNKNOWN WHETHER THE BREAST IMPLANT WAS ALSO REPLACED.

    Patient problems: Fluid Discharge

    MAUDE report 17625338 ↗

Other Mesh, Surgical devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.