FDA Adverse Event
Injury
Summary report: N
ATN AR SCREW 100MM STERILE
MDR report key: 1040461
·
Received May 8, 2008
Report
- Report Number
- 1818910-2008-01470
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- April 9, 2008
- Report Date
- April 9, 2008
- Manufacturer
- DEPUY ACE S.A. 'R.L.
- Product Code
- HSB
- PMA / PMN Number
- K042325
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- 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
REVISION SURGERY WAS NECESSARY BECAUSE THE TROCH NAIL ROTATED ANTERIORLY, CAUSING THE ANTI-ROTATION SCREW AND LAG SCREW TO CUT OUT. SURGEON SUSPECTED THAT ORIGINAL IMPLANTATION OF THE LAG SCREW WAS ANTERIOR, WHICH THEN LED TO THIS PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATN AR SCREW 100MM STERILE | 87HSB | HSB | DEPUY ACE S.A. 'R.L. | NA | DGNCJB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |