FDA Adverse Event
Injury
Summary report: N
SCREW
MDR report key: 2831481
·
Received November 14, 2012
Report
- Report Number
- 2520274-2012-03116
- Event Type
- Injury
- Date Received
- November 14, 2012
- Date of Event
- October 17, 2012
- Report Date
- October 17, 2012
- Product Code
- HWC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL
- 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. ADDITIONAL NARRATIVE: INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO PART OR LOT NUMBER WAS PROVIDED.
Description of Event or Problem · 1
A REPORT WAS RECEIVED REGARDING AN EXPLANT PROCEDURE TO REMOVE A FEMUR PLATE AND SCREWS; UNKNOWN REASON FOR THE EXPLANT. DURING THE PROCEDURE, THE SURGEON FOUND THAT TWO SCREWS WERE COLD-WELDED TO THE REVISING FEMUR PLATE. THE SURGEON USED CARBIDE DRILL BITS TO DRILL TO REMOVE THE SCREWS FROM THE PLATE. THE SCREWS AND PLATE WERE EXPLANTED WITH NO FRAGMENTS TO RETRIEVE. THE PLATE AND SCREWS WERE NOT BROKEN. THIS IS REPORT #2 OF 3 FOR THE SAME EVENT.
Description of Event or Problem · 1
PATIENT WAS REVISED DUE TO NON-UNION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCREW | SCREW | HWC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention |