FDA Adverse Event
Malfunction
Summary report: N
SCREW
MDR report key: 2960003
·
Received February 13, 2013
Report
- Report Number
- 2520274-2013-00869
- Event Type
- Malfunction
- Date Received
- February 13, 2013
- Report Date
- February 5, 2010
- Manufacturer
- SYNTHES (USA) WEST CHESTER, PA
- Product Code
- MNI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT. ACTUAL EVENT DATE NOT KNOWN. EXACT PART NUMBER COULD NOT BE IDENTIFIED. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION. AS NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. THERE IS NO FURTHER INFORMATION AVAILABLE ON THIS EVENT AND NO FURTHER INVESTIGATION CAN BE PERFORMED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE P.A. CLICKX SCREW DOES NOT HAVE THE LENGTH OF THE SCREW LASER ETCHED ON IT. DURING A CASE EVALUATION FOR P.A. CLICKX, THE NURSE INCORRECTLY GAVE THE SURGEON THE WRONG LENGTH SCREW WHICH THE SURGEON INSERTED. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 62519 | SCREW | MNI | SYNTHES (USA) WEST CHESTER, PA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |