FDA Adverse Event
Injury
Summary report: N
4.0 CANN.CANC.BONE SCREW
MDR report key: 1033565
·
Received April 23, 2008
Report
- Report Number
- 1818910-2008-01104
- Event Type
- Injury
- Date Received
- April 23, 2008
- Date of Event
- March 4, 2008
- Report Date
- March 24, 2008
- Manufacturer
- DEPUY ACE S.A. 'R.L.
- Product Code
- HWC
- PMA / PMN Number
- K903810
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
Description of Event or Problem · 1
ABDUCTION OSTEOTOMY WAS DONE WITH SCREWS AND THE PLATE OF OTHER COMPANY FOR CUBITUS VARUS. THE SCREW AND THE PLATE WERE FOUND BROKEN THROUGH X-RAY PICTURES. ANOTHER SURGERY WAS DONE TO REMOVE THE IMPLANTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 4.0 CANN.CANC.BONE SCREW | 87HWC | HWC | DEPUY ACE S.A. 'R.L. | NA | DDFB80 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR | Required Intervention |