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	04/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 could not be determined.Due to the legal process, if additional information is made available during legal proceedings, the information will be sent to product surveillance for further evaluation.To date, no additional information has been received.No further actions are required, a nonconformance was not confirmed.
Event or Problem Description
It was reported through a legal event that a 38 year old male patient underwent hernia repair surgery on or about (b)(6) 2017.During the hernia repair surgery, the surgeon implanted a strattice firm mesh.After surgery, the patient underwent an explant surgery on (b)(6) 2018, during which another strattice mesh product was implanted.The records indicate this is a strattice firm mesh as well.After that surgery, the patient underwent surgery for a recurrent hernia on (b)(6) 2019, and another explant surgery on (b)(6) 2020.This record is associated with the first device implanted on (b)(6) 2017 with explant date (b)(6) 2018.
Event or Problem Description
This is follow up#1 to report on 14/sept/2022, pmqa received notification from legal that the lot associated with this event was found through discovery and is sp100471-009.No other information was reported.As reported in the initial: it was reported through a legal event that a 38 year old male patient underwent hernia repair surgery on or about (b)(6) 2017.During the hernia repair surgery, the surgeon implanted a strattice firm mesh.After surgery, the patient underwent an explant surgery on (b)(6) 2018, during which another strattice mesh product was implanted.The records indicate this is a strattice firm mesh as well.After that surgery, the patient underwent surgery for a recurrent hernia on (b)(6) 2019, and another explant surgery on (b)(6) 2020.This record is associated with the first device implanted on (b)(6) 2017 with explant date (b)(6) 2018.
Additional Manufacturer Narrative
This is follow up#1 to report that on 14/sept/ 2022, pmqa received notification from legal that the lot associated with this event was found through discovery and is sp100471-009.No other information was provided.The internal investigation is pending and will be reported in a follow up report along with the investigation conclusion.As reported in the initial: this legal event is being reported as serious injury due to the reported recurrence with surgical intervention.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
This is follow up#2 to report the results from the internal investigation and the conclusion.The aware date of october 9, 2022 is based on when the batch record review was completed.As reported in follow up#1: this is follow up#1 to report on 14/sept/2022, pmqa received notification from legal that the lot associated with this event was found through discovery and is sp100471-009.No other information was reported.As reported in the initial: it was reported through a legal event that a 38 year old male patient underwent hernia repair surgery on or about (b)(6), 2017.During the hernia repair surgery, the surgeon implanted a strattice firm mesh.After surgery, the patient underwent an explant surgery on (b)(6) 2018, during which another strattice mesh product was implanted.The records indicate this is a strattice firm mesh as well.After that surgery, the patient underwent surgery for a recurrent hernia on january 9, 2019, and another explant surgery on (b)(6) 2020.This record is associated with the first device implanted on (b)(6) 2017 with explant date (b)(6) 2018.It was reported through a legal event that a 38 year old male patient underwent hernia repair surgery on or about (b)(6) 2017.During the hernia repair surgery, the surgeon implanted a strattice firm mesh.After surgery, the patient underwent an explant surgery on (b)(6) 2018, during which another strattice mesh product was implanted.The records indicate this is a strattice firm mesh as well.After that surgery, the patient underwent surgery for a recurrent hernia on (b)(6) 2019, and another explant surgery on (b)(6) 2020.This record is associated with the first device implanted on (b)(6) 2017 with explant date (b)(6) 2018.
Additional Manufacturer Narrative
This follow up is to report the results from the internal investigation and conclusion.Internal investigation into strattice lot sp100471 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/oct/2022, of the (b)(4) devices released to finished goods for lot sp100471, (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.As reported in follow up#1: this is follow up#1 to report that on 14/sept/ 2022, pmqa received notification from legal that the lot associated with this event was found through discovery and is sp100471-009.No other information was provided.The internal investigation is pending and will be reported in a follow up report along with the investigation conclusion.As reported in the initial: this legal event is being reported as serious injury due to the reported recurrence with surgical intervention.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: 14715913
• Report Number: 1000306051-2022-00110
• Device Sequence Number: 2176075
• Product Code: FTM
• UDI-Device Identifier: 00818410010096
• UDI-Public: 00818410010096
• 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: 2017
• 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,Followup,Followup
• Report Date (Section B): 10/13/2022

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: SP100471
• 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: 05/23/2022
• Supplement Date Received by Manufacturer: 09/14/2022; 10/09/2022
• Initial Report FDA Received Date: 06/16/2022
• Supplement Report FDA Received Date: 10/05/2022; 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 Age: 38 YR
• Patient Sex: Male