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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TUTOGEN MEDICAL GMBH STRATTICE¿ RECONSTRUCTIVE TISSUE MATRIX PORCINE DERMIS

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TUTOGEN MEDICAL GMBH STRATTICE¿ RECONSTRUCTIVE TISSUE MATRIX PORCINE DERMIS Back to Search Results
Lot Number NOT PROVIDED
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Cellulitis (1768); Hernia (2240)
Event Date 08/16/2016
Event Type  Injury  
Manufacturer Narrative
A follow up #2 report was submitted for this report incorrectly. There is no additional information for this event and therefore there is no need for a follow up report.
 
Manufacturer Narrative
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 three departures noted during records re-review for lot mp151501. One departure was associated with damage to one of the graft's packaging. The graft associated with the departure was destroyed. The second departure was associated with some grafts entered in the system with the wrong document type. However, the complaint graft was not involved or affected. The third departure was associated with exceeded airborne microbial count. Additional testing was performed and was acceptable. Bioburden testing on all grafts was within specification. The investigation concluded that these departures did not have a negative impact on the quality of the complaint graft. Xenografts manufactured from lot mp151501, 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 74 xenografts from lot mp151501 without related complaints. Based on our records re-review and the complaint information provided to date, it is more plausible that the patient's post-operative complications were associated with an event or source extrinsic to the xenograft implant.
 
Manufacturer Narrative
The reported complaint is not associated with a graft manufactured by rti surgical, inc.
 
Event Description
Rti surgical, inc. Received additional information on (b)(6) 2017 indicating that the allograft implanted in this patient was not a fortiva porcine dermis. The graft implanted was a strattice reconstructive tissue matrix. The reported complications were associated with the implanted strattice.
 
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 the unique identifiers are provided to rti.
 
Event Description
Rti surgical, inc (rti) received a complaint notification on 08/22/2017 indicating that a patient underwent implantation of a fortiva porcine dermis on an unknown date, as part of a hernia repair clinical study. The patient developed an abdominal cellulitis on (b)(6) 2016 and a post-operative wound dehiscence on (b)(6) 2016. Additional information has been requested. To date, rti has not received any additional information.
 
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Brand NameSTRATTICE¿ RECONSTRUCTIVE TISSUE MATRIX
Type of DevicePORCINE DERMIS
Manufacturer (Section D)
TUTOGEN MEDICAL GMBH
industriestr 6
neunkirchen, germany 91077
GM 91077
Manufacturer (Section G)
RTI SURGICAL, INC
11621 research circle
alachua FL 32615
Manufacturer Contact
leila kelly
11621 research circle
alachua, FL 32615
3864188888
MDR Report Key6870813
MDR Text Key110241520
Report Number3002719998-2017-00028
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142070
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 12/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberNOT PROVIDED
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/15/2017 Patient Sequence Number: 1
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