FDA Adverse Event
Injury
Summary report: N
MEMBRAGEL
MDR report key: 1880291
·
Received October 19, 2010
Report
- Report Number
- 1222315-2010-00015
- Event Type
- Injury
- Date Received
- October 19, 2010
- Date of Event
- August 26, 2010
- Report Date
- October 18, 2010
- Manufacturer
- BIORA AB
- Product Code
- NPK
- PMA / PMN Number
- K082111
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
MFR COMPLETED A REVIEW OF THE MFG RECORDS AND FOUND THE PRODUCT TO BE WITHIN SPECIFICATION.
Description of Event or Problem · 1
CLINICIAN REPORTS A GUIDED BONE REGENERATION (GBR) TREATMENT WAS CARRIED OUT ON (B)(6) 2010 ON AN EXTRACTION SOCKET WITH IMMEDIATE IMPLANT PLACEMENT TO FILL GAP. AT ONE MONTH F/U ON (B)(6) 2010, CLINICIAN REPORTS THAT THERE WAS SIGNIFICANT SWELLING IN VESTIBULE AND ANTIBIOTICS WAS ADMINISTERED. CLINICIAN REPORTS PAIN, SWELLING AND INFECTION. BOTH MEMBRANE AND IMPLANT ARE STILL STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEMBRAGEL | BARRIER MEMBRANE | NPK | BIORA AB | MEM031 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Required Intervention | ALLOGRAFT WITH TETRACYDINE |