FDA Adverse Event
Injury
Summary report: N
CORTICAL BONE SCR 38MM
MDR report key: 1080903
·
Received July 22, 2008
Report
- Report Number
- 1818910-2008-02832
- Event Type
- Injury
- Date Received
- July 22, 2008
- Report Date
- June 25, 2008
- Manufacturer
- DEPUY ACE S.A. 'R.L.
- Product Code
- HSB
- PMA / PMN Number
- K871539
- 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
IT WAS NOTED THAT THE SCREW WAS BROKEN WHEN THE DOCTOR TRIED TO REMOVE THE SCREW OUT OF THE PATIENT'S BODY DURING THE REVISION SURGERY. THE DOCTOR NEEDED TO MAKE ADDITIONAL INCISION TO REMOVE THE BROKEN TIP OF THE SCREW. NO PRODUCT REMAINS IN THE PATIENT'S BODY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CORTICAL BONE SCR 38MM | 87HSB | HSB | DEPUY ACE S.A. 'R.L. | NA | DGCBVN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |