FDA Adverse Event
Injury
Summary report: N
SCREW
MDR report key: 2870236
·
Received December 12, 2012
Report
- Report Number
- 2520274-2012-03824
- Event Type
- Injury
- Date Received
- December 12, 2012
- Report Date
- November 13, 2012
- Product Code
- HWC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS.
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: AN INVESTIGATION AND DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS THERE WAS NO PART OR LOT NUMBER PROVIDED AND THE DEVICE WAS NOT RETURNED.
Description of Event or Problem · 1
A REPORT WAS RECEIVED REGARDING THE REMOVAL OF A FEMUR LESS INVASIVE STABILIZATION SYSTEM (LISS) PLATE, FROM THE FEMUR SHAFT. THE MOST PROXIMAL SCREW WAS BROKEN AND THERE WAS A NON-UNION. THE LISS PLATE AND SIX SCREWS WERE REMOVED. THE PATIENT WAS REVISED WITH NEW DEVICES FROM ANOTHER MANUFACTURER. THIS IS REPORT # 5 OF 7 FOR THE SAME EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCREW | SCREW | HWC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention |