FDA Adverse Event
Injury
Summary report: N
RAPIDFLAP SPINDOWN CLAMP, 16MM
MDR report key: 2032625
·
Received March 29, 2011
Report
- Report Number
- 1032347-2011-00042
- Event Type
- Injury
- Date Received
- March 29, 2011
- Date of Event
- March 21, 2011
- Report Date
- March 21, 2011
- Manufacturer
- BIOMET MICROFIXATION
- Product Code
- GXN
- PMA / PMN Number
- K031034
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT HAD TWO SIDED FIXATION CLAMPS IMPLANTED ON (B)(6) 2011. THE SURGEON DISCOVERED THAT THE PATIENT DEVELOPED HIGH INTRACRANIAL PRESSURE AND THE CLAMPS WERE REMOVED ON (B)(6) 2011.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RAPIDFLAP SPINDOWN CLAMP, 16MM | BONE PLATE | GXN | BIOMET MICROFIXATION | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |