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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 25, FIRM; MESH, SURGICAL
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STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 25, FIRM; MESH, SURGICAL Back to Search Results
Catalog Number 2025002
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Hernia (2240)
Date of Event 10/30/2019
Type of Reportable Event Serious Injury
Event or Problem Description
Limited information was reported through legal, that a (b)(6) male patient underwent hernia repair surgery and was implanted with strattice lots sp100461-147 and sp100388-001 on (b)(6) 2016.On (b)(6) 2019 the patient had a repair of the recurrent ventral hernia with component separation and removal of previously placed mesh.This record is associated with lot sp100461-147 - record 1 of 2.
 
Additional Manufacturer Narrative
Internal investigation into strattice lot sp100461 included a review of the reported information, review of the device history records and review of the complaint history records.The device was not returned to lifecell for evaluation.Investigation results revealed no remarkable findings with no similar complaints reported against the lot and no related deviations or nonconformances revealed during manufacturing.The lot was terminally sterilized within the process parameters and met all qc release criteria.To date, of the (b)(4) devices released to finished goods for lot sp100461, (b)(4) have been distributed and (b)(4) reported as implanted.
 
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Brand Name
STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 25, FIRM
Common Device Name
MESH, SURGICAL
MDR Report Key12752468
Report Number1000306051-2021-03071
Device Sequence Number4560429
Product Code FTM
UDI-Device Identifier00818410010157
UDI-Public00818410010157
Combination Product (Y/N)N
Initial Reporter StateMO
Initial Reporter CountryUS
PMA/510(K) Number
K070560
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2019
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 11/04/2021
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 Number2025002
Device Lot NumberSP100461
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/14/2021
Initial Report FDA Received Date11/04/2021
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 Number1
Concomitant Medical Products
and Therapy/Usage Dates
NO INFORMATION REPORTED
Outcome Attributed to Adverse Event Required Intervention;
Patient Age68 YR
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