COPIOS PERICARDIUM MEMBRANE
Report
- Report Number
- 3002924436-2024-00019
- Event Type
- Injury
- Date Received
- January 16, 2025
- Report Date
- March 20, 2025
- Manufacturer
- TUTOGEN MEDICAL, GMBH
- Product Code
- NPL
- PMA / PMN Number
- K073097
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- 003
Narratives
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION.
ON 12/19/2024, RTI SURGICAL, INC. AND TUTOGEN MEDICAL GMBH (TMI), A WHOLLY SUBSIDIARY OF RTI SURGICAL, RECEIVED A COMPLAINT FROM A DENTIST IN GERMANY THAT INDICATED THE FOLLOWING: THE DOCTOR USED THE COPIOSA MATERIAL IN THE SINUS SIX TIMES WHERE HE NOTICED THERE WAS INFLAMMATION. ACCORDING TO THE DOCTOR HE WAS NOT INFORMED ABOUT CONTRAINDICATIONS, THERE WERE NO INDICATIONS IN THE PACKAGE LEAFLET OR BROCHURE. THE COPIOSA MEMBRANE DID NOT REABSORB AFTER SIX MONTHS. THE COPIOSA MEMBRANE WAS COMPLETELY REMOVED FROM THE SINUS. THE DOCTOR ALSO INDICATED FAILURE IN LATERAL AUGMENTATION WHEN USING THE COPIOSA MATERIAL. TO DATE, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED TO RTI FOR REVIEW.
RTI SURGICAL, INC. D/B/A/ EVERGEN AND TUTOGEN MEDICAL GMBH (TMI), A WHOLLY SUBSIDIARY OF EVERGEN, RECEIVED ADDITIONAL INFORMATION THAT INDICATED THE FOLLOWING: THE GRAFT THAT WAS INITIALLY REPORTED TO BE ASSOCIATED WITH THE COMPLAINT WAS INCORRECT. THE COMPLAINT INVOLVED A COPIOS PARTICULATE XENOGRAFT NOT A COPIOS PERICARDIUM MEMBRANE. COPIOS PARTICULATE XENOGRAFTS AND OTHER SIMILAR GRAFTS ARE NOT DISTRIBUTED IN THE US BY EVERGEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 751865 | COPIOS PERICARDIUM MEMBRANE | DENTAL MEMBRANE | NPL | TUTOGEN MEDICAL, GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |