GENTRIX SURGICAL MATRIX THICK
Received Oct 17, 2018 · Event occurred Sep 18, 2018
Report 3005920706-2018-00017 · MDR key 7975181
Device
Generic name
Gentrix Surgical Matrix Thick
Manufacturer
Acell, Inc.Model number
PSMT2030Catalog number
PSMT2030
Lot number
009841
Product problems
- Material Split, Cut or Torn
- Material Split, Cut or Torn
Patient
0 YR
- No Consequences Or Impact To Patient
- No Known Impact Or Consequence To Patient
- No Consequences Or Impact To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THIS MDR IS BEING SUBMITTED DUE TO THE REPORTED SUTURE PULL THROUGH THAT OCCURRED DURING THE INITIAL PLACEMENT OF THE ACELL DEVICE. THE DEVICE WAS THEREFORE NOT USED, THE SURGEON REQUESTED AND USED A DEVICE FROM A DIFFERENT MANUFACTURER WHICH RESULTED IN A DELAY (INCREASED SURGERY TIME). THE PATIENT DID NOT EXPERIENCE ANY COMPLICATION DUE TO THE SUTURE PULL THROUGH. THE DEVICE WAS RETURNED TO ACELL FOR FURTHER INVESTIGATION. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT IDENTIFIED NO DEVIATIONS IN THE PRODUCTION PROCESS THAT FALL OUTSIDE OF SPECIFICATION. THE DEVICE WAS MANUFACTURED AND DISTRIBUTED STERILE IN COMPLIANCE WITH ACELL'S OPERATING PROCEDURES AND FEDERAL, STATE, AND LOCAL LAWS AND REGULATIONS.
Description of Event or Problem
ON (B)(6) 2018, 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 REQUESTED AND USED A DEVICE FROM A DIFFERENT MANUFACTURER 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.