GentrixRecalls & reported problems across all models

We found 13 models of Gentrix by Acell, Inc. in the FDA's device registry (GUDID). Together they are named in 26 adverse event reports in the FDA's MAUDE database, received between May 8, 2018 and Apr 27, 2022 — classified as 21 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Gentrix problems

Gentrix models

13 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Gentrix® MSPL1015

  Mesh, surgical, collagen, plastic and reconstructive surgery
  6 reports
• Gentrix® PSMT2030

  Mesh, surgical, collagen, large abdominal wall defects
  4 reports
• Gentrix® PSMT1620A

  Mesh, surgical
  3 reports
• Gentrix® MSPL0507

  Mesh, surgical
  2 reports
• Gentrix® PSMX1015

  Mesh, surgical, collagen, plastic and reconstructive surgery
  2 reports
• Gentrix® PSMT3040

  Mesh, surgical
  2 reports
• Gentrix® PSMX0710

  Mesh, surgical, collagen, plastic and reconstructive surgery
  1 report
• Gentrix PSMT1620

  Mesh, surgical, collagen, large abdominal wall defects
  1 report
• Gentrix® PSMT2020

  Mesh, surgical
  1 report
• Gentrix® PSMT2025

  Mesh, surgical, collagen, plastic and reconstructive surgery
  1 report
• Gentrix® PSMX0710

  Mesh, surgical, collagen, diaphragmatic hernia
  1 report
• Gentrix® PSMX1015

  Mesh, surgical, collagen, plastic and reconstructive surgery
  1 report
• Gentrix® PSM1015

  Mesh, surgical
  1 report

Recent Gentrix adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2022Material Fragmentation; Material Fragmentation

  A FACILITY REPORTED A GENTRIX SURGICAL MATRIX RIPPED DURING SUTURE IN MULTIPLE PLACES. THE MATRIX WAS USED FOR AN ABDOMINAL WALL RECONSTRUCTION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14219760 ↗
• InjuryJan 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, ACELL, INC. WAS NOTIFIED THAT A PATIENT EXPERIENCED A FEVER AND SEROMA POST IMPLANTATION OF TWO GENTRIX DEVICES. THE GENTRIX DEVICES WERE IMPLANTED ON (B)(6) 2020 FOR A C-SECTION. THE DEVICES WERE PLACED IN THE UTERUS INCISION WITHIN THE MUSCLE AND FASCIA. THE DEVICES WERE CUT DOWN TO A SMALLER SIZE TO ACCOMMODATE THE SMALLER INCISION AND THEN TACKED IN PLACE IN 4 CORNERS. ON (B)(6) 2020, THE PATIENT STATED HAVING A FEVER AND WENT TO THE ER. THE PATIENT WAS ADMITTED, AND WAS SHOWING FLUID IN TWO SPACES FROM THE CAT SCAN. THE PATIENT WAS PLACED ON ANTIBIOTICS DURING THIS VISIT AND WAS DISCHARGED A DAY LATER. THE PATIENT MADE AN ADDITIONAL VISIT TO THE ER ON (B)(6) 2020 FOR A FEVER AND ABDOMINAL PAIN. THE PATIENT WAS GIVEN ANTIBIOTICS DURING THIS VISIT AND DISCHARGED A DAY LATER. THERE WAS NO SURGICAL INTERVENTION TO RESOLVE THE SEROMA FOR BOTH VISITS TO THE ER ON (B)(6) 2020 AND (B)(6) 2020. THE GENTRIX DEVICES REMAINS IN PLACE AND ARE FUNCTIONING AS INTENDED.

  Patient problems: Fever; Seroma

  MAUDE report 11121314 ↗
• InjuryJan 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, ACELL, INC. WAS NOTIFIED THAT A PATIENT EXPERIENCED A FEVER AND SEROMA POST IMPLANTATION OF TWO GENTRIX DEVICES. THE GENTRIX DEVICES WERE IMPLANTED ON (B)(6) 2020 FOR A C-SECTION. THE DEVICES WERE PLACED IN THE UTERUS INCISION WITHIN THE MUSCLE AND FASCIA. THE DEVICES WERE CUT DOWN TO A SMALLER SIZE TO ACCOMMODATE THE SMALLER INCISION AND THEN TACKED IN PLACE IN 4 CORNERS. ON (B)(6) 2020, THE PATIENT STATED HAVING A FEVER AND WENT TO THE ER. THE PATIENT WAS ADMITTED, AND WAS SHOWING FLUID IN TWO SPACES FROM THE CAT SCAN. THE PATIENT WAS PLACED ON ANTIBIOTICS DURING THIS VISIT AND WAS DISCHARGED A DAY LATER. THE PATIENT MADE AN ADDITIONAL VISIT TO THE ER ON (B)(6) 2020 FOR A FEVER AND ABDOMINAL PAIN. THE PATIENT WAS GIVEN ANTIBIOTICS DURING THIS VISIT AND DISCHARGED A DAY LATER. THERE WAS NO SURGICAL INTERVENTION TO RESOLVE THE SEROMA FOR BOTH VISITS TO THE ER ON (B)(6) 2020 AND (B)(6) 2020. THE GENTRIX DEVICES REMAINS IN PLACE AND ARE FUNCTIONING AS INTENDED.

  Patient problems: Fever; Seroma

  MAUDE report 11121311 ↗
• InjuryJan 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 12/10/2020, ACELL, INC. WAS NOTIFIED THAT A GENTRIX DEVICE WAS DEBRIDED DUE TO A HERNIA RECURRENCE AND ABSCESS. THE GENTRIX DEVICE WAS IMPLANTED ON (B)(4) 2020 DUE TO A VENTRAL HERNIA. THE GENTRIX WAS USED IN A ONLAY FASCIAL REPAIR WITHOUT A DRAIN. ON (B)(6) 2020, THE PATIENT WAS SHOWN TO HAVE HERNIA RECURRENCE AND FLUID BUILDING. THE SURGEON REOPERATED AND DEBRIDED AREA AROUND GENTRIX DEVICE. THE GENTRIX DEVICE WAS NOT EXPLANTED BUT DEBRIDED TO ALLOW FOR THE BRIDGING OF THE POSTERIOR FASCIA WITH ANOTHER MANUFACTURER'S DEVICE, PHASIX. THE GENTRIX DEVICE REMAINS IN PLACE AND IS FUNCTIONING AS INTENDED.

  Patient problems: Abscess; Hernia

  MAUDE report 11121188 ↗
• InjuryNov 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 10/21/2020, ACELL, INC. WAS NOTIFIED THAT A GENTRIX DEVICE WAS PARTIALLY EXPLANTED DUE A SEROMA. THE GENTRIX DEVICE WAS IMPLANTED ON (B)(6) 2020 DUE TO A RECURRENT INCISIONAL HERNIA; A PRIOR MESH SEPRAMESH WAS REMOVED AT THIS TIME. THE GENTRIX WAS PLACED IN THE RECTO-RECTUS SPACED WITH A DRAIN. PATIENT HAD A PRE-EXISTING INFECTION WHERE THE GENTRIX WAS PLACED. ON (B)(6) 2020 THE PATIENT WAS SHOWN TO HAVE FLUID BUILDING UP ABOVE THE DEVICE, SURGEON REOPERATED AND DEBRIDED AREA AROUND GENTRIX DEVICE. THE MAJORITY OF THE ACELL DEVICE (>90%) REMAINS IN THE RETRORECTUS SPACE AND IS FUNCTIONING AS INTENDED.

  Patient problems: Seroma

  MAUDE report 10836236 ↗
• 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 ↗
• InjuryApr 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 3/25/2020, ACELL, INC. "RECIEVED" A MEDWATCH "NOTIFICAFTION" THAT A PATIENT EXPERIENCED AN ABSCESS FOLLOWING A VENTRAL AND INCISIONAL HERNIA REPAIR REINFORCED WITH GENTRIX THICK AND A HYSTERECTOMY ON (B)(6) 2019. THE ORIGINAL SURGERY ON (B)(6) 2019 WAS A DOUBLE PROCEDURE A VENTRAL AND INCISION HERNIA REPAIR AND A HYSTERECTOMY INCLUDING WORK THAT INVOLVED THE PERINEUM WHICH POTENTIALLY CAUSED A CONTAMINATED OPERATIVE FIELD. THE VENTRAL AND INCISION HERNIA REPAIR WAS NECESSARY DUE TO A PRIOR SURGERY CONDUCTED SOME TIME IN 2006. THE 2006 SURGERY WAS FOR AN INTERNAL HERNIA THAT CAUSED BOWEL OBSTRUCTION, SPECIFICALLY IT WAS A LEFT PARADUODENAL HERNIA AT THE JD JUNCTION THAT CAUSED THE BOWEL OBSTRUCTION. THERE WAS A TEAR IN MESENTERY OF THE SMALL BOWEL. DURING THE SURGERY, ADHESION WERE DISCOVERED ; HOWEVER THE PATIENT HAD NO PRIOR SURGERY BEFORE THIS PROCEDURE IN 2006. ADDITIONAL, HERNIAS DEVELOPED AS A RESULT OF THIS SURGERY IN 2006. THE (B)(6) 2019 SURGERY WAS CONDUCTED VIA A MIDLINE INCISION FROM THE BREAST BONE TO THE PUBIS. AN ANTERIOR ONLAY PATCH OF THE GENTRIX THICK DEVICE WAS PLACED ON THE MUSCLE FASCIA AND SUTURED WITH INTERRUPTED SUTURES. THERE WERE TWO DRAINS PLACED DURING

  Patient problems: Abscess; Fever

  MAUDE report 9982755 ↗
• InjuryApr 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 3/25/2020, ACELL, INC. "RECIEVED" A MEDWATCH "NOTIFICAFTION" THAT A PATIENT EXPERIENCED AN ABSCESS FOLLOWING A VENTRAL AND INCISIONAL HERNIA REPAIR REINFORCED WITH GENTRIX THICK AND A HYSTERECTOMY ON (B)(6) 2019. THE ORIGINAL SURGERY ON (B)(6) 2019 WAS A DOUBLE PROCEDURE A VENTRAL AND INCISION HERNIA REPAIR AND A HYSTERECTOMY INCLUDING WORK THAT INVOLVED THE PERINEUM WHICH POTENTIALLY CAUSED A CONTAMINATED OPERATIVE FIELD. THE VENTRAL AND INCISION HERNIA REPAIR WAS NECESSARY DUE TO A PRIOR SURGERY CONDUCTED SOME TIME IN 2006. THE 2006 SURGERY WAS FOR AN INTERNAL HERNIA THAT CAUSED BOWEL OBSTRUCTION, SPECIFICALLY IT WAS A LEFT PARADUODENAL HERNIA AT THE JD JUNCTION THAT CAUSED THE BOWEL OBSTRUCTION. THERE WAS A TEAR IN MESENTERY OF THE SMALL BOWEL. DURING THE SURGERY, ADHESION WERE DISCOVERED ; HOWEVER THE PATIENT HAD NO PRIOR SURGERY BEFORE THIS PROCEDURE IN 2006. ADDITIONAL, HERNIAS DEVELOPED AS A RESULT OF THIS SURGERY IN 2006. THE (B)(6) 2019 SURGERY WAS CONDUCTED VIA A MIDLINE INCISION FROM THE BREAST BONE TO THE PUBIS. AN ANTERIOR ONLAY PATCH OF THE GENTRIX THICK DEVICE WAS PLACED ON THE MUSCLE FASCIA AND SUTURED WITH INTERRUPTED SUTURES. THERE WERE TWO DRAINS PLACED DURING

  Patient problems: Abscess; Fever

  MAUDE report 9982753 ↗
• InjuryFeb 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, ACELL, INC. WAS NOTIFIED BY A PHYSICIAN THAT THE PATIENT EXPERIENCED A HERNIA RECURRENCE. THE DEVICE IMPLANTATION SURGERY WAS A REDO LAPAROSCOPIC HIATAL HERNIA REPAIR WITH NISSEN FUNDOPLICATIONON ON (B)(6) 2020. THE PATIENT EXPERIENCED A SECOND HERNIA RECURRENCE AND WAS REOPERATED ON (B)(6) 2020, WHEN SOME OF THE DEVICE WAS PARTIALLY EXPLANTED BUT THE DEVICE WAS OTHERWISE MAINTAINED SUPERIORLY AND MEDIALLY.

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

  MAUDE report 9683892 ↗
• 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 ↗
• InjuryJan 2, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ON 12/6/19, ACELL, INC. BECAME AWARE THAT AN ACELL DEVICE WAS EXPLANTED DUE TO A BOWEL OBSTRUCTION. THE ACELL DEVICE WAS IMPLANTED (B)(6) 2019 AND EXPLANTED ON (B)(6) 2019. WE ARE SUBMITTING THIS REPORT NOW, HOWEVER, ADDITIONAL INFORMATION HAS BEEN REQUESTED. AN UPDATE "WLLL" BE PROVIDED UPON RECIEPT OF MORE INFORMATION.

  Patient problems: Obstruction/Occlusion

  MAUDE report 9538229 ↗
• MalfunctionDec 20, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ON"11/2119," ACELL, INC. BECAME AWARE THAT SUTURE PULL THROUGH OCCURRED WITH AN ACELL DEVICE DURING AN INCISIONAL HERNIA REPAIR. THE DEVICE WAS NOT USED. THE SURGEON DECIDED TO USE AN UNKNOWN, NON-ACELL DEVICE WHICH RESULTED IN A SURGICAL DELAY (INCREASED SURGERY TIME). THE PATIENT DID NOT EXPERIENCE ANY COMPLICATION DUE TO THE SUTURE PULL THROUGH NOR THE INCREASED SURGERY TIME.

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

  MAUDE report 9500492 ↗
• InjuryDec 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 11/8/1209, ACELL, INC. WAS NOTIFIED BY A SURGEON THAT A PATIENT EXPERIENCED A SEROMA FOUR (4) MONTHS POST OPERATIVE VENTRAL HERNIA REPAIR WITH AN ACELL DEVICE PLACED AS AN ONLAY ON (B)(6) 2019. THE PATIENT EXPERIENCED A WOUND DEHISCIENCE AT REPAIR SITE ON (B)(6) 2019. THE WOUND WAS DRAINED AND DEBRIDED ON (B)(6) 2019, THE WOUND WAS CULTURED WITH NO INFECTION PRESENT.

  Patient problems: Seroma

  MAUDE report 9418117 ↗
• MalfunctionJul 27, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2019, ACELL, INC. BECAME AWARE THAT SUTURE PULL THROUGH OCCURRED WITH AN ACELL DEVICE DURING THE REINFORCEMENT OF A VENTRAL HERNIA REPAIR. THE DEVICE WAS NOT USED. THE SURGEON DECIDED TO CLOSE THE HERNIA PRIMARILY WHICH RESULTED IN A SURGICAL DELAY (INCREASED SURGERY TIME). THE PATIENT DID NOT EXPERIENCE ANY COMPLICATION DUE TO THE SUTURE PULL THROUGH NOR THE INCREASED SURGERY TIME.

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

  MAUDE report 8834607 ↗
• MalfunctionJun 14, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2019, ACELL, INC. BECAME AWARE THAT SUTURE PULL THROUGH OCCURRED WITH AN ACELL DEVICE DURING A HERNIA REPAIR. THE DEVICE WAS NOT USED. THE SURGEON DECIDED TO USE A DEVICE FROM ANOTHER MANUFACTURER. THE PATIENT DID NOT EXPERIENCE ANY COMPLICATION DUE TO THE SUTURE PULL THROUGH NOR THE INCREASED SURGERY TIME.

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

  MAUDE report 8701269 ↗

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