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Gentrix® PSMX1015 (UDI 00386190001387)Recalls & reported problems

Acell, Inc. · Gentrix® Surgical Matrix 10 x 15 cm · Class 2 · Implant

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00386190001387), received between Jan 25, 2020 and Jul 22, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

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
  • Improper or Incorrect Procedure or Method1
  • Off-Label Use1
  • Use of Device Problem1

Patient problems

  • No Consequences Or Impact To Patient1
  • No Known Impact Or Consequence To Patient1
  • Unspecified Infection1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 22, 2020Off-Label Use; Use of Device Problem; Improper or Incorrect Procedure or Method; Off-Label Use; Use of Device Problem; Improper or Incorrect Procedure or Method

    ON 6/26/2020 ACELL RECEIVED NOTIFICATION FROM A PHYSICIAN THAT A PATIENT DEVELOPED AN INFECTION AFTER A HAIR RESTORATION PROCEDURE WHICH INVOLVED SCALP INJECTIONS WITH MICROMATRIX RECONSTITUTED WITH PLATELET RICH PLASMA (PRP). THE PROCEDURE WAS CONDUCTED ON (B)(6) 2020. THE PATIENT WAS PRESCRIBED ANTIBIOTICS.

    Patient problems: Unspecified Infection

    MAUDE report 10311907 ↗
  • InjuryJan 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ON 12/27/2019, ACELL, INC. WAS NOTIFIED BY A PHYSICIAN THAT THE PATIENT EXPERIENCED A HERNIA RECURRENCE. THE ORIGINAL SURGERY IN (B)(6) 2019 (EXACT DAY UNKNOWN) WAS FOR AN UMBILICAL HERNIA WHERE THE DISTAL TO PROXIMAL TACKING WAS PERFORMED WITH ETHICON SECURESTRAP AND THE ACELL DEVICE. DURING REOPERATION IN (B)(6) 2019 (EXACT DAY UNKNOWN) FOR THE RECURRENT HERNIA, THE PHYSICIAN STATED THE ACELL DEVICE WAS PARTIALLY REMODELED AND HAD TO BE PARTIALLY EXPLANTED TO REPAIR THE RECURRENT HERNIA. SURGEON STATED THE HERNIA RECURRENCE OCCURRED DUE TO EITHER CONTRACTURE RETRACTION OR BODY HABITUS.

    Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

    MAUDE report 9630376 ↗

Other Mesh, surgical, collagen, plastic and reconstructive surgery 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.