FDA Adverse Event
Injury
Summary report: N
ITST INTERTROCHANTERIC/SUBTROCHANTERIC FIXATION LAG SCREW
MDR report key: 413912
·
Received August 30, 2002
Report
- Report Number
- 1822565-2002-00102
- Event Type
- Injury
- Date Received
- August 30, 2002
- Date of Event
- March 4, 2002
- Report Date
- July 31, 2002
- Manufacturer
- ZIMMER, INC.
- Product Code
- NDE
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
LAG SCREW CUT OUT OF FEMORAL NECK AFTER 32 DAYS. SURGEON STATED "FRACTURE COLLAPSED DUE TO VARUS DISLOCATION." RE-IMPLANTED NAIL AND LAG SCREW (SEATED LOWER) AND ADDED A 5.5MM M/DN SCREW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ITST INTERTROCHANTERIC/SUBTROCHANTERIC FIXATION LAG SCREW | LAG SCREW | NDE | ZIMMER, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Hospitalization| R |