FDA Adverse Event
Malfunction
Summary report: N
MEDPOR IMPLANT
MDR report key: 1883002
·
Received October 15, 2010
Report
- Report Number
- 1057129-2010-00019
- Event Type
- Malfunction
- Date Received
- October 15, 2010
- Report Date
- August 11, 2010
- Manufacturer
- POREX SURGICAL
- Product Code
- JOF
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FOLLOWING A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT NUMBER 86002-D285H08, IT WAS DETERMINED THAT ALL PROCESSES AND TEST CRITERIA ARE WITHIN THE MEDPOR IMPLANT FINISHED PRODUCT SPECIFICATION.
Description of Event or Problem · 1
THE DOCTOR'S ASSISTANT STATED THAT THEY ORDERED A MEDPOR CHIN IMPLANT FOR A SURGERY. THE DOCTOR'S ASSISTANT STATED THAT THE IMPLANT BROKE IN TWO DURING A PROCEDURE AND THE DOCTOR WAS ABLE TO PROCEED BY USING A BACK-UP IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDPOR IMPLANT | PREFORMED CRANFACIAL SHAPES | JOF | POREX SURGICAL | NA | D285H08 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |