FDA Adverse Event
Injury
Summary report: N
INFUSE BONE GRAFT SMALL KIT
MDR report key: 1402844
·
Received June 11, 2009
Report
- Report Number
- 1030489-2009-00486
- Event Type
- Injury
- Date Received
- June 11, 2009
- Report Date
- April 28, 2009
- 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 BY BOAKYE ET AL IN A PUBLICATION ENTITLED "ANTERIOR CERVICAL DISCECTOMY AND FUSION INVOLVING A POLYETHERETHERKETONE SPACER AND BONE MORPHOGENETIC PROTEIN" (J. NEUROSURG: SPINE 2: 521-525, 2005) THAT A PATIENT UNDERWENT AN ACDF PROCEDURE USING RHBMP-2/ACS. POSTOPERATIVELY, THE PATIENT DEVELOPED TRANSIENT C5 PARESIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INFUSE BONE GRAFT SMALL KIT | INFUSE BONE GRAFT | NEK | MEDTRONIC SOFAMOR DANEK USA, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention | PEEK INTERBODY DEVICE| ATLANTIS CERVICAL PLATE |