MAUDE Adverse Event Report: INTEGRA - ACELL(COLUMBIA) GENTRIX SURGICAL MATRIX THICK 20 X 30 CM

Model Number	PSMT2030
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
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.
Additional Manufacturer Narrative
The gentrix surgical matrix was not returned for evaluation (as per customer, product not available); therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.

• Brand Name: GENTRIX SURGICAL MATRIX THICK 20 X 30 CM
• Common Device Name: GENTRIX
• Manufacturer (Section D): INTEGRA - ACELL(COLUMBIA); 6640 eli whitney drive; 6640 eli whitney drive; columbia MD
• Manufacturer (Section G): INTEGRA - ACELL(COLUMBIA); 6640 eli whitney drive; columbia MD
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 14219760
• Report Number: 3005920706-2022-00004
• Device Sequence Number: 17470017
• Product Code: FTM
• UDI-Device Identifier: 00386190001561
• UDI-Public: 00386190001561
• Combination Product (Y/N): N
• PMA/510(K) Number: K041140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PSMT2030
• Device Catalogue Number: PSMT2030
• Device Lot Number: 025270
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2022
• Supplement Date Received by Manufacturer: 05/03/2022
• Initial Report FDA Received Date: 04/27/2022
• Supplement Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown