FDA Adverse Event
Injury
Summary report: N
INFUSE BONE GRAFT
MDR report key: 1002313
·
Received February 22, 2008
Report
- Report Number
- 1030489-2008-00097
- Event Type
- Injury
- Date Received
- February 22, 2008
- Report Date
- February 20, 2008
- Manufacturer
- MEDTRONIC SOFAMOR DANEK USA, INC.
- Product Code
- NEK
- PMA / PMN Number
- P000058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT A TLIF AT AN UNK LEVEL USING RHBMP-2/ACS AND A PEEK INTERBODY DEVICE. AT AN UNK TIME POST-OP, IT WAS NOTED THAT THE PATIENT HAD DEVELOPED AN "EPIDURAL HEMATOMA." A SURGICAL INTERVENTION WAS REPORTEDLY PERFORMED AT AN UNK TIME POST-OP TO EVACUATE THE HEMATOMA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INFUSE BONE GRAFT | INFUSE BONE GRAFT | NEK | MEDTRONIC SOFAMOR DANEK USA, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK YR | Required Intervention |