FDA Adverse Event
Injury
Summary report: N
STRAUMANN BONE CERAMIC
MDR report key: 2153295
·
Received June 30, 2011
Report
- Report Number
- 1222315-2011-00024
- Event Type
- Injury
- Date Received
- June 30, 2011
- Date of Event
- January 9, 2011
- Report Date
- June 30, 2011
- Manufacturer
- INSTITUT STRAUMANN AG
- Product Code
- LYC
- PMA / PMN Number
- K040646
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
REVIEW OF BATCH RECORDS INDICATE THAT THE PRODUCT WAS RELEASED ACCORDING TO SPECIFICATIONS.
Description of Event or Problem · 1
ON (B)(6) 2010, USE OF MEMBRAGEL, 0.8 ML ARTICLE NUMBER 070.101, BATCH Y6370 AND STRAUMANN BONE CERAMIC, 0.4-0.7MM, 0.25G, ARTICLE 070.203 BATCH G9802. CLINICIAN REPORTS ON (B)(6) 2011 AFTER USING MEMBRAGEL AND BONE CERAMIC, THE PT HAD SWELLING; ON (B)(6) 2011, STILL A FISTULA PRESENT; ON (B)(6) 2011, NO SWELLING ANYMORE. INFECTION WAS TREATED WITH DALACIN + CHX.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STRAUMANN BONE CERAMIC | SYNTHETIC BONE GRAFTING MATERIAL | LYC | INSTITUT STRAUMANN AG | G9802 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |