FDA Adverse Event
Other
Summary report: N
STRAUMANN BONE CERAMIC
MDR report key: 1120668
·
Received August 14, 2008
Report
- Report Number
- 1222315-2008-00009
- Event Type
- Other
- Date Received
- August 14, 2008
- Date of Event
- July 9, 2008
- Report Date
- August 14, 2008
- Manufacturer
- BIORA
- Product Code
- LYC
- PMA / PMN Number
- K040646
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
THE BATCH RECORD REVIEW SHOWS THAT THE PRODUCT IS WITHIN SPECIFICATION.
Description of Event or Problem · 1
IN 2008, IMPLANT WAS PLACED AND STRAUMANN BONECERAMIC WAS USED TO STRENGTHEN BUCCAL BONE WALL. THREE MONTHS LATER, A CROWN WAS INSERTED AT WHICH TIME NO ABNORMALITIES WERE DETERMINED. TWO MONTHS LATER, PATIENT COMPLAINED OF BUCCAL SWELLING. WHEN CLINICIAN PRESSED ON SITE (TISSUE), THERE WAS SLIGHT PUS ABSCESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STRAUMANN BONE CERAMIC | SYNTHETIC BIPHASIC CALCIUM PHOSPHATE | LYC | BIORA | F9123 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Other |