FDA Adverse Event
Other
Summary report: N
INFUSE BONE GRAFT
MDR report key: 907521
·
Received August 31, 2007
Report
- Report Number
- 1030489-2007-00265
- Event Type
- Other
- Date Received
- August 31, 2007
- Report Date
- August 6, 2007
- Manufacturer
- MEDTRONIC SOFAMOR DANEK USA, INC.
- Product Code
- NEK
- PMA / PMN Number
- P000058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MFR FOR EVAL. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.
Description of Event or Problem · 1
IT WAS REPORTED IN THE EUROPEAN SPINE JOURNAL (2007) BY VAIDYA, R. ET AL VIA AN ARTICLE ENTITLED "COMPLICATIONS OF ANTERIOR CERVICAL DISCECTOMY AND FUSION USING RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN-2" THAT A PT HAD UNDERGONE AN ACDF USING RHBMP-2/ACS AND PEEK CAGE(S). POST-OPERATIVELY, THE PT DEVELOPED PRE-VERTEBRAL SWELLING AND DYSPHAGIA OF A SEVERITY THAT PROMPTED THE SURGEON TO EXTEND THE PT'S HOSPITAL STAY UNTIL THE SYMPTOMS HAD SUFFICIENTLY RESOLVED.
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 | YR | Hospitalization |