MAUDE Adverse Event Report: TUTOGEN MEDICAL GMBH FORTIVA PORCINE DERMIS; PORCINE DERMIS - SURGICAL MESH

Model Number	PD2025
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Seroma (2069); Hernia (2240)
Date of Event	07/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information provided to date indicated that the xenograft remains implanted and not available for evaluation.Therefore, a comprehensive re-review will be conducted of the manufacturing records, sterilization run reports, environmental monitoring results, quality control / assurance reviews and release, and the complaint database for related complaints.Once results are available, a follow up will be submitted.
Event or Problem Description
Rti surgical, inc (rti) received a complaint notification on (b)(4) 2017 indicating that a patient underwent implantation of a fortiva porcine dermis at an unknown date, as part of a hernia repair clinical study.On (b)(6) 2017, the patient developed a seroma (unknown location).To date, rti has not received any additional information.
Additional Manufacturer Narrative
Methods: the xenograft was not returned for evaluation.Therefore, a comprehensive re-review of manufacturing records, sterilization run reports, quality control / assurance reviews and release, and the complaint database for related complaints associated with the lot was conducted.Results: there were two departures noted during records re-review for lot mp152601.One departure was associated with exceeded airborne bioburden.However, additional testing was performed and was acceptable.Bioburden testing on all the grafts was within specification.The second departure was associated with the storage temperature being exceeded in the abattoir.A risk analysis indicated that there was no risk to the product quality due to these departures.Xenografts manufactured from lot mp152601, underwent a validated sterilization methodology: tutoplast®, which includes terminal sterilization by gamma irradiation after packaging.Serial id (b)(4) met all rti/tmi specifications and release criteria prior to distribution.To date, rti/tmi has manufactured and distributed a total of 117 xenograft from the lot without related complaints.Based on our records re-review and the complaint information provided to date, it is more plausible that the patient's operative complications were associated with an event of source extrinsic to the xenograft implants.

• Brand Name: FORTIVA PORCINE DERMIS
• Common Device Name: PORCINE DERMIS - SURGICAL MESH
• Manufacturer (Section D): TUTOGEN MEDICAL GMBH; industriestrasse 6; neunkirchen am brand, germany 91077 ; GM 91077
• MDR Report Key: 6999293
• Report Number: 3002719998-2017-00034
• Device Sequence Number: 1006420
• Product Code: FTM
• UDI-Device Identifier: 04041543312065
• UDI-Public: (01)04041543312065(17)180731(10)MP152601
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K142070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2017

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: Physician
• Device Expiration Date: 07/31/2018
• Device Model Number: PD2025
• Device Catalogue Number: PD2025
• Device Lot Number: MP152601
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/06/2017
• Supplement Date Received by Manufacturer: 12/08/2017
• Initial Report FDA Received Date: 11/03/2017
• Supplement Report FDA Received Date: 12/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other