COPIOS PERICARDIUM MEMBRANE
Report
- Report Number
- 3002924436-2023-00008
- Event Type
- Injury
- Date Received
- January 18, 2024
- Report Date
- January 18, 2024
- Manufacturer
- TUTOGEN MEDICAL, GMBH
- Product Code
- NPL
- PMA / PMN Number
- K073097
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- 003
Narratives
UNIQUE IDENTIFIERS HAVE NOT BEEN PROVIDED TO DATE. IN ORDER TO CONDUCT A COMPREHENSIVE BATCH RECORDS ANALYSIS, THIS INFORMATION IS NEEDED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
ON 12/19/2023, RTI SURGICAL, INC. AND TUTOGEN MEDICAL GMBH (TMI), A WHOLLY SUBSIDIARY OF RTI SURGICAL, RECEIVED A COMPLAINT FROM ZIMVIE UK. THE REPORTED COMPLAINT INDICATED THAT THE PATIENT UNDERWENT A DENTAL PROCEDURE AT TOOTH SITES #35-37. A PUROS® ALLOGRAFT CUSTOMIZED BLOCK AND A COPIOS PERICARDIUM MEMBRANE WERE IMPLANTED. ON AN UNKNOWN DATE, THE PATIENT DEVELOPED AN INFECTION, WOUND DEHISCENCE EXPOSING THE BONE BLOCK AND NON-INTEGRATION. THE PATIENT WILL HAVE TO RETURN AT A FUTURE DATE TO COMPLETE THE PROCEDURE. TO DATE, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED TO RTI FOR REVIEW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 818530 | COPIOS PERICARDIUM MEMBRANE | DENTAL MEMBRANE | NPL | TUTOGEN MEDICAL, GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |