FDA Adverse Event
Other
Summary report: N
MEDPOR IMPLANT
MDR report key: 1392904
·
Received May 21, 2009
Report
- Report Number
- 1057129-2009-00002
- Event Type
- Other
- Date Received
- May 21, 2009
- Report Date
- May 20, 2009
- Manufacturer
- POREX SURGICAL
- Product Code
- HPZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DATES OF IMPLANTATION: (B)(6) 2008. (B)(6) 2008. (B)(6) 2008. LOT NUMBER INFO WAS NOT PROVIDED BY THE DOCTOR FOR FURTHER EVAL, THEREFORE, NO CONCLUSION CAN BE DRAWN. NO INFO REGARDING THE CONDITION OF THE PT AFTER REMOVAL OF THE IMPLANTS COULD BE OBTAINED FROM THE SURGEON.
Description of Event or Problem · 1
THE DOCTOR STATED THAT HE HAD THREE PTS THAT RECEIVED A MEDPOR TITAN CRANIAL CURVE IMPLANT IN (B)(6) 2008. THE DOCTOR STATED THAT EACH PT DEVELOPED AN INFECTION APPROX FIVE TO SIX WEEKS AFTER SURGERY. THE DOCTOR REPORTED THAT THE MEDPOR IMPLANTS WERE REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDPOR IMPLANT | FACIAL RECONSTRUCTION | HPZ | POREX SURGICAL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |