FDA Adverse Event
Injury
Summary report: N
MEDPOR SURGICAL IMPLANT MATERIAL PREFORMED CRANIAL AND FACIAL IMPLANT
MDR report key: 2853084
·
Received August 7, 2012
Report
- Report Number
- 1057129-2012-00005
- Event Type
- Injury
- Date Received
- August 7, 2012
- Date of Event
- July 10, 2012
- Report Date
- August 6, 2012
- Manufacturer
- STRYKER CRANIOMAXILLOFACIAL GEORGIA
- Product Code
- FWP
- PMA / PMN Number
- K922489
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE CONDUCTED AS LOT NUMBER INFORMATION WAS NOT PROVIDED FOR FURTHER REVIEW.
Description of Event or Problem · 1
THE NURSE REPORTED THAT THE DOCTOR WAS IMPLANTING A MEDPOR TWO PIECE SMALL CHIN IMPLANT AND THE RIGHT SECTION OF THE IMPLANT SNAPPED. THE DOCTOR USED A BACKUP IMPLANT TO COMPLETE THE SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDPOR SURGICAL IMPLANT MATERIAL PREFORMED CRANIAL AND FACIAL IMPLANT | IMPLANT | FWP | STRYKER CRANIOMAXILLOFACIAL GEORGIA | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |