FDA Adverse Event
Other
Summary report: N
MEDPOR IMPLANT
MDR report key: 1413817
·
Received July 8, 2009
Report
- Report Number
- 1057129-2009-00005
- Event Type
- Other
- Date Received
- July 8, 2009
- Date of Event
- March 13, 2009
- Report Date
- July 8, 2009
- Manufacturer
- POREX SURGICAL
- Product Code
- HPZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FOLLOWING A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT NUMBER 80014-D232M11, IT WAS DETERMINED THAT ALL PROCESSES AND TEST CRITERIA ARE WITHIN THE MEDPOR IMPLANT FINISHED PRODUCT SPEC.
Description of Event or Problem · 1
THE DOCTOR STATED THAT THE PT RECEIVED A MEDPOR SST SPHERE IMPLANT IN (B)(6) 2009. THE DOCTOR STATED THAT AT APPROX FOUR WEEK POST OP, DURING A FOLLOW-UP EXAM, IT WAS NOTICED THAT THE IMPLANT HAD EXPOSED. THE DOCTOR REPORTED THAT IN (B)(6) 2009, THE MEDPOR IMPLANT WAS NOT REMOVED AND THE EXPOSURE OF THE IMPLANT WAS PATCHED USING (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDPOR IMPLANT | FACIAL RECONSTRUCTION | HPZ | POREX SURGICAL | NA | D232M11 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Other |