FDA Adverse Event
Injury
Summary report: N
DYNAMIC AXIAL FIXATION SYSTEM
MDR report key: 862699
·
Received June 7, 2007
Report
- Report Number
- 2183449-2007-00010
- Event Type
- Injury
- Date Received
- June 7, 2007
- Date of Event
- May 9, 2007
- Report Date
- June 6, 2007
- Manufacturer
- ORTHOFIX INC.
- Product Code
- JDW
- PMA / PMN Number
- K831576
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING APPLICATION OF THE OASIS FIXATOR, THE PROXIMAL MEDIAL CLAMP COVER COULD NOT BE COMPLETELY TIGHTENED OVER ONE OF THE BONE SCREWS. THE DR TIGHTENED DOWN THE CLAMP AS MUCH AS POSSIBLE AND LEFT THE FIXATOR ON THE PT. ANOTHER OASIS FIXATOR WAS SENT TO THE DR. THE PT RETURNED TO THE DR'S OFFICE WHERE THE CLAMP WAS REPLACED WITH THE NEW ONE REMOVED FROM THE REPLACEMENT FIXATOR. THE PT WILL CONTINUE TREATMENT WITH THE FIXATOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DYNAMIC AXIAL FIXATION SYSTEM | OASIS FIXATOR | JDW | ORTHOFIX INC. | 25000L | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Required Intervention |