FDA Adverse Event
Malfunction
Summary report: N
EXTRACTION SCREWDRIVER
MDR report key: 1033468
·
Received April 23, 2008
Report
- Report Number
- 1719045-2008-00046
- Event Type
- Malfunction
- Date Received
- April 23, 2008
- Date of Event
- March 25, 2008
- Report Date
- April 1, 2008
- Manufacturer
- SYNTHES MONUMENT
- Product Code
- HXX
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SUBJECT DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED. NO INVESTIGATION COULD BE PERFORMED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED.
Description of Event or Problem · 1
DURING AN ACDF, THE NUB ON THE EXTRACTION SCREWDRIVER BROKE OFF IN THE TI CERVICAL SELF-RETAINING SCREW. THE SURGEON DECIDED TO LEAVE THE NUB INSIDE THE IMPLANTED SCREW HEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXTRACTION SCREWDRIVER | EXTRACTION SCREWDRIVERS | HXX | SYNTHES MONUMENT | NA | 561215D06 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | SCREW |