MAUDE Adverse Event Report: INTEGRA - ACELL(COLUMBIA) UNKNOWN GENTRIX SURGICAL MATRIX

Catalog Number XXX-GENTRIX

Device Problem Degraded (1153)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Complaint sample was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.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 Description

Medwatch mw5104878: a patient reported he had an inguinal hernia repair with an unknown gentrix surgical matrix device initially performed on (b)(6) 2021.The surgeon reported that there was no sign of the gentrix surgical matrix device during explant on (b)(6) 2021.This suggests that the gentrix device would most likely have been a psm (3 layer) or a psmx (6 layer) and that the device was completely resorbed after 65 days or 81 days depending on the event date being on (b)(6) 2021 versus on (b)(6) 2021.The patient required surgical intervention and hospitalization.

Manufacturer Narrative

Complaint sample was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.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 Description

Medwatch mw5104878: a patient reported he had an inguinal hernia repair with an unknown gentrix surgical matrix device initially performed on (b)(6) 2021.The surgeon reported that there was no sign of the gentrix surgical matrix device during explant on (b)(6) 2021.This suggests that the gentrix device would most likely have been a psm (3 layer) or a psmx (6 layer) and that the device was completely resorbed after 65 days or 81 days depending on the event date being on (b)(6) 2021 versus on (b)(6) 2021.The patient required surgical intervention and hospitalization.

• Brand Name: UNKNOWN GENTRIX SURGICAL MATRIX
• Type of Device: 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: 12965327
• MDR Text Key: 285238171
• Report Number: 3005920706-2021-00005
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• PMA/PMN Number: K182259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-GENTRIX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1