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

Catalog Number	1010002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	02/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This legal event is being reported as serious injury due to the reported recurrence with device explant.The lot associated with this event was not reported and remains unknown; therefore a review of the device history records could not be performed.No strattice devices were returned for evaluation.Based on the limited information reported, a relationship between the event and strattice cannot be confirmed.Due to the legal process, if additional information is made available during legal proceedings, a supplemental report will be submitted.
Event or Problem Description
Limited information was reported through a legal event that a patient underwent hernia repair surgery on or about (b)(6) 2016 and (b)(6) 2020.During the patient's hernia repair surgeries, the surgeon implanted strattice mesh.The patient returned to the hospital on or about (b)(6) 2020.On or about (b)(6) 2020, the patient underwent a small bowel resection and removal of mesh.This record is associated with the second device implanted on (b)(6) 2020.
Event or Problem Description
This is follow up #1 to report on september 14, 2022, pmqa received notification from legal that the lot associated with this event was found through discovery and is sp200165-127.No other information was reported.As reported in the initial: limited information was reported through a legal event that a patient underwent hernia repair surgery on or about (b)(6) 2016 and (b)(6) 2020.During the patient's hernia repair surgeries, the surgeon implanted strattice mesh.The patient returned to the hospital on or about (b)(6) 2020.On or about (b)(6) 2020, the patient underwent a small bowel resection and removal of mesh.This record is associated with the second device implanted on january 29, 2020.
Additional Manufacturer Narrative
Internal investigation into strattice lot sp200165 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 09/21/2022, of the 168 devices released to finished goods for lot sp200165, 156 have been distributed with 66 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.As reported in the initial: this legal event is being reported as serious injury due to the reported recurrence with device explant.The lot associated with this event was not reported and remains unknown; therefore a review of the device history records could not be performed.No strattice devices were returned for evaluation.Based on the limited information reported, a relationship between the event and strattice cannot be confirmed.Due to the legal process, if additional information is made available during legal proceedings, a supplemental report will be submitted.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 10, FIRM
• Common Device Name: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 13654510
• Report Number: 1000306051-2022-00023
• Device Sequence Number: 5750260
• Product Code: FTM
• UDI-Device Identifier: 00818410010096
• UDI-Public: 00818410010096
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K070560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2022

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: 1010002
• Device Lot Number: SP200165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2022
• Supplement Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 10/05/2022
• 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: Female