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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TUTOGEN MEDICAL GMBH FORTIVA PERFORATED DERMIS PORCINE DERMIS

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TUTOGEN MEDICAL GMBH FORTIVA PERFORATED DERMIS PORCINE DERMIS Back to Search Results
Lot Number PD17210001
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Breast Cancer (1759); Necrosis (1971); Seroma (2069)
Event Date 08/15/2019
Event Type  Injury  
Manufacturer Narrative
The implant was not returned for evaluation. Therefore, a comprehensive records re-review was conducted. There were no departures noted that would negatively impact the xenograft implants manufactured from lot pd17210001. Manufacturing records review indicated that serial id (b)(4) met all specifications and release criteria prior to distribution. Rti/tmi has manufactured and distributed a total of 24 xenograft implants from the lot without related complaints. Porcine dermis xenograft implants udnergo a validated sterilization method: tutoplast®, which includes terminal sterilization by gamma irradiation after packaging. To date, our investigation indicates that the reported complications are more likely associated with one or more extrinsic factors, rather than an intrinsic property of fortiva porcine dermis xenograft.
 
Event Description
Rti surgical, inc (rti) and tutogen medical (b)(4))tmi, a wholly owned subsidiary of rti, received a complaint which indicated that a patient, enrolled in the fortiva appear trial, underwent nipple sparing mastectomy of the left breast with implantation of a fortiva perforated porcine dermis graft and a silicone breast implant on (b)(6) 2019. The patient received antibiotics during surgery and two drains were left in place in the axila. On (b)(6) 2019, she developed necrosis of the left breast bar area which was considered to be procedure related and not related to the fortiva implant. The drains were removed on (b)(6) 2019 and the patient was discharged. On (b)(6) 2019, the patient underwent necrosis ablation and on (b)(6) 2019, a third of the fortiva graft was removed. Upon follow up on (b)(6) 2019, good wound healing was noted. A seroma was seen on ultrasound which was drained, revealing a serous fluid. The patient is doing well. To date, no additional information has been received.
 
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Brand NameFORTIVA PERFORATED DERMIS
Type of DevicePORCINE DERMIS
Manufacturer (Section D)
TUTOGEN MEDICAL GMBH
industriestrabe
neunkirchen am brand 97077
GM 97077
Manufacturer Contact
leila kelly
11621 research circle
alachua, FL 32615
3864188888
MDR Report Key9365162
MDR Text Key185489691
Report Number3002924436-2019-00012
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeGM
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
Report Date 07/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2021
Device Lot NumberPD17210001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/22/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/30/2018
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: 11/22/2019 Patient Sequence Number: 1
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