FDA Adverse Event
Injury
Summary report: N
INFUSE BONE GRAFT
MDR report key: 1020027
·
Received March 27, 2008
Report
- Report Number
- 1030489-2008-00155
- Event Type
- Injury
- Date Received
- March 27, 2008
- Report Date
- March 14, 2008
- Manufacturer
- MEDTRONIC SOFAMOR DANEK USA, INC.
- Product Code
- NEK
- PMA / PMN Number
- P000058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, 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 A PATIENT UNDERWENT A POSTERIOR CERVICAL FUSION USING RHBMP-2/ACS. THE PATIENT SUBSEQUENTLY DEVELOPED A COLLECTION OF FLUID POSTERIORLY THAT REQUIRED IRRIGATION AND DEBRIDEMENT. THE PATIENT'S STATUS IS UNKNOWN.
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 | Required Intervention |