FDA Adverse Event
Other
Summary report: N
OSTEOVATION INJECT BONE VOID FILLER
MDR report key: 2464125
·
Received February 14, 2012
Report
- Report Number
- 3003890476-2012-00001
- Event Type
- Other
- Date Received
- February 14, 2012
- Date of Event
- November 21, 2011
- Report Date
- February 14, 2012
- Manufacturer
- SKELETAL KINETICS
- Product Code
- GXP
- PMA / PMN Number
- K051784
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INITIAL COMPLAINT INFORMATION RECEIVED ON (B)(4) 2011, WAS EVALUATED AS OFF-LABEL USE AND NOT A REPORTABLE EVENT. HOWEVER, ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2012, WAS EVALUATED AND IT WAS DETERMINED TO BE A REPORTABLE EVENT.
Description of Event or Problem · 1
THE DEVICE, OSTEOVATION, WAS USED IN THE POSTERIOR FOSSA TO FILL A BONE VOID; THE DEVICE MALFUNCTIONED AFTER IMPLANTATION THAT RESULTED IN THE PATIENT TO SUSTAIN A CEREBRAL SPINAL FLUID (CSF) LEAK THAT NECESSITATED A SECOND SURGICAL PROCEDURE AFTER IMPLANTATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OSTEOVATION INJECT BONE VOID FILLER | BONE VOID FILLER | GXP | SKELETAL KINETICS | 390-2005 | 11082612 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |