MAUDE Adverse Event Report: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 30, FIRM; MESH, SURGICAL

Catalog Number	2030002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	03/11/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through a legal event that a (b)(6) male patient underwent hernia repair surgery on or about (b)(6) 2016.During the hernia repair surgery, the surgeon implanted a strattice reconstructive tissue matrix item 2030002, lot sp100368 mesh in him.After surgery, 5 years later, the patient had a revision surgery on (b)(6) 2021.
Additional Manufacturer Narrative
Internal investigation into strattice lot sp100368 included a review of the reported information, review of the device history records, and a review of the complaint history records.The investigation resulted in no remarkable findings, including no other complaints reported against the lot and no deviations or related non-conformance's revealed during processing.The lot was terminally sterilized within the process parameters and met all qc release criteria.(b)(4).Based on our internal review with no remarkable findings, a relationship between the strattice and this event could not be determined.No further actions are required as a nonconformance could not be confirmed.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 30, FIRM
• Common Device Name: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 14457481
• Report Number: 1000306051-2022-00095
• Device Sequence Number: 4515262
• Product Code: FTM
• UDI-Device Identifier: 00818410010393
• UDI-Public: 00818410010393
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K070560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 2030002
• Device Lot Number: SP100368
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 05/20/2022
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NO INFORMATION REPORTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male