FDA Adverse Event
Injury
Summary report: N
HTR-PEKK
MDR report key: 3832283
·
Received April 14, 2014
Report
- Report Number
- 3009582362-2014-00003
- Event Type
- Injury
- Date Received
- April 14, 2014
- Date of Event
- February 28, 2014
- Report Date
- April 14, 2014
- Manufacturer
- OXFORD PERFORMANCE MATERIALS
- Product Code
- GXN
- PMA / PMN Number
- K121818
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE PK614108-A WAS REMOVED APPROXIMATELY SIX MONTHS AFTER THE IMPLANTATION DATE ((B)(6) 2013) DUE TO AN INFECTION. THE IMPLANTATION WAS PERFORMED AT (B)(6). "OUR 1.5 NEURO PLATING SYSTEM (LOANER SET)" "2 OR 3 DOUBLE Y-PLATE 01-PLATE 01-7404 AND 2-3-4-HOLE STRAIGHT (01-7050)" "WERE USED TO FIXATE THE ORIGINAL IMPLANT." THE REVISION SURGERY (EXPLANTATION) WAS PERFORMED ON (B)(6) 2014 AT UNIVERSITY HENA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 227277 | HTR-PEKK | CRANIAL IMPLANT | GXN | OXFORD PERFORMANCE MATERIALS | PK614108-A | IG3150M-13F001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening |