MAUDE Adverse Event Report: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 16, FIRM; MESH, SURGICAL

Catalog Number	1016002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	12/14/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This legal event is being reported as serious injury due to the reported recurrence with surgical intervention.Internal investigation into strattice lot sp100211 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-conformances revealed during processing.The lot was terminally sterilized within the process parameters and met all qc release criteria.As of 09/20/2022, of the (b)(4) devices released to finished goods for lot sp100211, (b)(4) have been distributed with (b)(4) reported as implanted.Based on our internal investigation with no remarkable findings, and without relevant patient factors, a relationship between the strattice and this event could not be determined.Due to the legal process, if additional information is made available during legal proceedings, a supplemental report will be submitted.
Event or Problem Description
It was reported through a legal event that a 59 year old female patient underwent hernia repair surgery on or about (b)(6) 2013.During the hernia repair surgery, the surgeon implanted a strattice mesh, lot number is s11166 and ref number is 1620002.On or about (b)(6) 2015, the patient underwent surgery for a chronic seroma of the abdominal wall and infection.Part of the mesh was cut out and the seroma cavity was excised.On or about (b)(6) 2015, the patient presented with a large recurrent hernia and underwent another hernia repair surgery where the surgeon implanted another strattice mesh.The records indicate this is a lifecell matrix strattice firm mesh, the lot number is (b)(4) and catalog number is 1620002.After surgery, the patient returned to the hospital on or about (b)(6) 2018 and underwent a bilateral component separation, explant of prior mesh, debridement of abdominal wall, and recurrent hernia repair with implant of another strattice mesh.The records indicate the mesh implanted in (b)(6) 2018 is a lifecell strattice perforated mesh.The lot number is sp100567 and the catalog number is 1620002p.This record is associated with (b)(4), implanted (b)(6) 2015 with date of occurrence (b)(6) 2018 as it is not clear which device was explanted during this surgery as part of device s11166 was explanted previously.The 'reherniation' event for lot s11166 was captured under 2633218.There is no allegation against lot sp100567 implanted in (b)(6) 2018.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 16, FIRM
• Common Device Name: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 15595551
• Report Number: 1000306051-2022-00149
• Device Sequence Number: 2328413
• Product Code: FTM
• UDI-Device Identifier: 00818410010119
• UDI-Public: 00818410010119
• 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: 2015
• Device Explanted Year: 2018
• 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): 09/21/2022

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: 1016002
• Device Lot Number: SP100211
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2022
• Initial Report FDA Received Date: 10/13/2022
• 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 Sex: Unknown