FDA Adverse Event
Malfunction
Summary report: N
PRO OSTEON 500
MDR report key: 1030808
·
Received April 17, 2008
Report
- Report Number
- 2242816-2008-00054
- Event Type
- Malfunction
- Date Received
- April 17, 2008
- Date of Event
- April 9, 2008
- Report Date
- April 11, 2008
- Manufacturer
- EBI, L.P.
- Product Code
- MBS
- PMA / PMN Number
- P860005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DHR REVIEW SHOWED THAT THE REPORTED PART # /LOT# MET ALL APPLICABLE SPECS.
Description of Event or Problem · 1
IT WAS REPORTED THAT PRO OSTEON 500 WAS IMPLANTED IN 2002 FOR CERVICAL FUSION, AND THAT THE PT IS CURRENTLY EXPERIENCING PELVIC PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRO OSTEON 500 | MBS | EBI, L.P. | 202302 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |