FDA Adverse Event
Malfunction
Summary report: N
PLATE
MDR report key: 2841402
·
Received October 23, 2012
Report
- Report Number
- 2520274-2012-02422
- Event Type
- Malfunction
- Date Received
- October 23, 2012
- Date of Event
- September 7, 2012
- Report Date
- September 24, 2012
- Product Code
- HRS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT.
Description of Event or Problem · 1
A DEVICE REPORT FROM (B)(6) INDICATED A HOSPITAL IN (B)(6) REPORTED. PT FELL FROM HIS OWN HEIGHT IN RIGHT HIP REGION. DURING THE PROCEDURE, THE SURGEON WAS RE-TIGHTENING A SCREW AND THE SCREW HEAD BROKE OFF. THE SHAFT OF THE SCREW REMAINS IN THE PT. IT WAS NOTED SURGEON DID NOT RETRIEVE THE SCREW SHAFT DUE TO PT'S BAD HEALTH CONDITION. THIS IS 2 OF 2 REPORTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PLATE | HRS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | SCREW| PLATE |