FDA Adverse Event
Injury
Summary report: N
MEDPOR IMPLANT
MDR report key: 2111706
·
Received June 2, 2011
Report
- Report Number
- 1057129-2011-00011
- Event Type
- Injury
- Date Received
- June 2, 2011
- Date of Event
- February 23, 2011
- Report Date
- May 31, 2011
- Manufacturer
- STRYKER CRANIOMAXILLOFACIAL GEORGIA
- Product Code
- FWP
- PMA / PMN Number
- K922489
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE REPRESENTATIVE FROM THE DOCTOR'S OFFICE INDICATED THAT THE EXPLANTATION WAS NOT DUE TO THE IMPLANT. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THIS LOT AND ALL PROCESSES AND TEST PARAMETERS WERE WITHIN THE MEDPOR IMPLANT SPECIFICATION. DEVICE NOT RETURNED.
Description of Event or Problem · 1
A REPRESENTATIVE FROM THE DOCTOR'S OFFICE REPORTED THAT THE IMPLANT WAS REMOVED DUE TO A CSF LEAK. PATIENT CONDITION IS GOOD AFTER IMPLANT REMOVAL. AT THE FOLLOW UP VISIT THERE WERE NO ADDITIONAL CONCERNS OR LEAKS. THE DOCTOR'S REPRESENTATIVE REPORTED THAT THE EXPLANTATION WAS NOT DUE TO THE IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDPOR IMPLANT | MEDPOR SURGICAL IMPLANT MATERIAL PREFORMED CRANIAL AND FACIAL IMPLANT | FWP | STRYKER CRANIOMAXILLOFACIAL GEORGIA | NA | E019N13 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |