STRATTICE¿ RECONSTRUCTIVE TISSUE MATRIX
Report
- Report Number
- 3002719998-2017-00025
- Event Type
- Injury
- Date Received
- September 15, 2017
- Date of Event
- July 19, 2016
- Report Date
- October 26, 2017
- Manufacturer
- TUTOGEN MEDICAL GMBH
- Product Code
- FTM
- PMA / PMN Number
- K142070
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
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.
THE REPORTED COMPLAINT IS NOT ASSOCIATED WITH A GRAFT MANUFACTURED BY RTI SURGICAL, INC.
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 ENTEROCUTANEUS FISTULA ON (B)(6) 2016 AND A SEROMA ON (B)(6) 2016 (UNKNOWN SPECIFIC LOCATIONS). ADDITIONAL INFORMATION HAS BEEN REQUESTED. TO DATE, RTI HAS NOT RECEIVED ANY ADDITIONAL INFORMATION.
RTI SURGICAL, INC RECEIVED ADDITIONAL INFORMATION ON 10/11/2017 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 649117 | STRATTICE¿ RECONSTRUCTIVE TISSUE MATRIX | PORCINE DERMIS | FTM | TUTOGEN MEDICAL GMBH | NOT PROVIDED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |