FDA Adverse Event
Injury
Summary report: N
CORTICAL SCREW 150/40
MDR report key: 569442
·
Received February 1, 2005
Report
- Report Number
- 2183449-2004-00008
- Event Type
- Injury
- Date Received
- February 1, 2005
- Date of Event
- December 13, 2004
- Report Date
- December 28, 2004
- Manufacturer
- ORTHOFIX, SRL.
- Product Code
- JDW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE SHEFFIELD FRAME/FIXATOR WAS APPLIED FOR CHARCOT FOOT RECONSTRUCTION. AT A FOLLOW-UP VISIT SEVEN MONTHS POST-OP IT WAS NOTICED THROUGH THE X-RAYS THE 3 SCREWS (99-60165) AND CONNECTING ROD (81038A) WERE BROKEN. THE DOCTOR REPLACED THE CONNECTING ROD, TWO BROKEN SCREWS, AND THEN HE ADDED A WIRE TO SUPPORT THE THIRD SCREW THAT WAS LEFT IN THE PT. SINCE THE THIRD SCREW BROKE IN THE MIDDLE OF THE BONE (THREADED PART OF THE SCREW AND HAD A GOOD AND STABLE PURCHASE, THE DOCTOR DECIDED NOT TO REMOVE IT. THE PT CONTINUED TREATMENT WITH THE SHEFFIELD FRAME/FIXATOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CORTICAL SCREW 150/40 | SCREW | JDW | ORTHOFIX, SRL. | 99-60165 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |