COPIOS PERICARDIUM MEMBRANE
Report
- Report Number
- 3002924436-2025-00026
- Event Type
- Injury
- Date Received
- August 8, 2025
- Report Date
- October 9, 2025
- Manufacturer
- TUTOGEN MEDICAL GMBH (TMI)
- Product Code
- NPL
- PMA / PMN Number
- K073097
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- 003
Narratives
TUTOGEN CONDUCTED A BATCH DOCUMENTATION REVIEW FOR SERIAL ID (B)(6) MANUFACTURED FROM LOT NZA22170130. BATCH DOCUMENTATION REVIEW INDICATED THAT SERIAL ID (B)(6) WAS MANUFACTURED TO SPECIFICATION AND MET ALL ACCEPTANCE / INSPECTION CRITERIA PRIOR TO DISTRIBUTION. ONE DEPARTURE FROM STANDARD OPERATING PROCEDURES WAS NOTED DURING THE RE-REVIEW FOR LOT NZA22170130. THE DEPARTURE DID NOT DIRECTLY AFFECT THE PRODUCT. TUTOGEN HAS MANUFACTURED AND DISTRIBUTED (B)(4) COPIOS PERICARDIUM MEMBRANE XENOGRAFTS FROM LOT NZA22170130 WITHOUT RELATED COMPLAINTS. ALTHOUGH IMPLANT THERAPY IS HIGHLY SUCCESSFUL AND PREDICTABLE, IT IS NOT WITHOUT POSSIBLE EARLY AND/OR LATE COMPLICATIONS. DEHISCENCE, INFLAMMATION AND LOSS OF GINGIVAL THICKNESS (FOREIGN BODY REACTION) ARE BOTH ASSESSED AS NON-SERIOUS. FOREIGN BODY REACTION AND DEHISCENCE ARE LISTED IN THE CURRENT VALID IFU FOR COPIOS PERICARDIUM MEMBRANE. GINGIVAL RECESSION IS USUALLY CAUSED BY LOCAL INFLAMMATION (WITH OR WITHOUT INFECTION), WHICH FREQUENTLY ACCOMPANIES A DENTAL PROCEDURE. IT IS MORE PLAUSIBLE THAT THE POST-OPERATIVE COMPLICATIONS ARE ASSOCIATED WITH A SOURCE OR EVENT EXTRINSIC TO THE COPIOS PERICARDIUM MEMBRANE.
A COMPREHENSIVE BATCH RECORD ANALYSIS IS BEING CONDUCTED. ONCE THE RESULTS ARE AVAILABLE, A FOLLOW-UP REPORT WIL BE SUBMITTED.
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 PATIENT IS A NON-SMOKER WITH VERY GOOD ORAL HYGIENE AND NO BRUXISM. HIS DENTAL PROCEDURE CONSISTED OF A LASER INCISION, FORMATION OF A MUCOPERIOSTEAL FLAP, EXPOSURE OF THE BONE, REMOVAL OF SOFT TISSUE FROM THE BONE, IMPLANT DRILLING, PERIOSTEAL INCISION WITH A SCALPEL, BONE FRESHENED WITH A ROSE HEAD BUR AROUND THE AREA TO BE AUGMENTED, COLLECTED AUTOGENOUS BONE FOR AUGMENTATION, REMOVED STERILE COPIOS PERICARDIUM MEMBRANE AND ROUNDED THE CORNERS WITH STERILE SCISSORS, COPIOS PERICARDIUM MEMBRANE WAS IMPLANTED, 1-2 DROPS OF STERILE NACL APPLIED TO MOISTEN, MEMBRANE ADAPTED UNDER PERIOSTEUM, FLAP ADAPTED AND SUTURED WITH SUPRAMID 4/0 WITHOUT SUTURING THE COPIOS PERICARDIUM MEMBRANE, SALIVA-TIGHT CLOSURE. ABOUT TWO WEEKS AFTER THE PROCEDURE, THE SUTURES WERE REMOVED, DEHISCENCE WAS OBSERVED, AND THE MUCOUS MEMBRANE WAS IRRITATED AT ITS EDGE. ONE WEEK LATER, MUCOSA HAD FORMED OVER THE MEMBRANE. ALTHOUGH THE REPORTER INITIALLY STATED THAT SHE SAW A CONNECTION BETWEEN THE GUM RECESSION AND THE TUTOGEN PRODUCT, THE COPIOS PERICARDIUM MEMBRANE WAS NOT REMOVED. FORMATION OF THE MUCOUS MEMBRANE SEEMED TO HAVE BEEN DELAYED, BUT THE HEALING PROCESS WAS NOT COMPLETELY INTERRUPTED. TO DATE, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED TO EVERGEN FOR REVIEW. .
ON 07/09/2025, RTI SURGICAL, INC. D/B/A EVERGEN AND TUTOGEN MEDICAL GMBH (TMI), A WHOLLY SUBSIDIARY OF EVERGEN, RECEIVED A COMPLAINT THAT INDICATED THE PATIENT UNDERWENT A DENTAL PROCEDURE ON (B)(6) 2025 WITH IMPLANTATION OF A COPIOUS PERICARDIUM MEMBRANE. DURING THE PROCEDURE, THE PATIENT EXPERIENCED A GINGIVAL REACTION TO THE MEMBRANE WHICH RESULTED IN THE LOSS OF GINGIVAL THICKNESS BY 2MM. TO DATE, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED TO EVERGEN FOR REVIEW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2161595 | COPIOS PERICARDIUM MEMBRANE | BOVINE PERICARDIUM MEMBRANE, PRODUCT CODE NPL | NPL | TUTOGEN MEDICAL GMBH (TMI) | NZA22170130 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Male | Other |