FDA Adverse Event
Injury
Summary report: N
ATN LAG SCREW 110MM STERILE
MDR report key: 1243064
·
Received November 21, 2008
Report
- Report Number
- 1818910-2008-05152
- Event Type
- Injury
- Date Received
- November 21, 2008
- Date of Event
- October 3, 2008
- Report Date
- October 22, 2008
- Manufacturer
- DEPUY ACE S.A. 'R.L.
- Product Code
- HSB
- PMA / PMN Number
- K042325
- Removal / Correction Number
- N/A
- 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
THE DOCTOR FOUND THAT THE LAG SCREW PROTRUDED THE JOINT SURFACES OF FEMORAL HEAD, ANOTHER SURGERY WAS DONE TO REMOVE THE LAG SCREW AND A/R LAG SCREW OUT OF THE PATIENT'S BODY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATN LAG SCREW 110MM STERILE | 87HSB | HSB | DEPUY ACE S.A. 'R.L. | N/A | DGDB3M |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | N/A | Required Intervention |