FDA Adverse Event
Injury
Summary report: N
PATIENT SPECIFIC IMPLANT
MDR report key: 1307308
·
Received February 6, 2009
Report
- Report Number
- 2530088-2009-00015
- Event Type
- Injury
- Date Received
- February 6, 2009
- Date of Event
- June 1, 2008
- Report Date
- January 29, 2009
- Manufacturer
- SYNTHES BRANDYWINE
- Product Code
- GXN
- PMA / PMN Number
- K033868
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
APPROXIMATE DATE OF EVENT: 2008. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. A REVIEW OF THE MANUFACTURING RECORDS HAS BEEN REQUESTED.
Description of Event or Problem · 1
PATIENT DEVELOPED AN ASEPTIC EFFUSION AFTER CRANIOPLASTY. IMPLANT WAS REMOVED AND ORIGINAL BONE FLAP WAS REASSEMBLED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PATIENT SPECIFIC IMPLANT | PATIENT SPECIFIC IMPLANT | GXN | SYNTHES BRANDYWINE | NA | 5638793 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention |