FDA Adverse Event
Malfunction
Summary report: N
4.0MM TI CANC EXPANSIONHEAD SCREW SELF-TAPPING 14MM
MDR report key: 3033561
·
Received April 3, 2013
Report
- Report Number
- 2520274-2013-01802
- Event Type
- Malfunction
- Date Received
- April 3, 2013
- Date of Event
- March 7, 2013
- Report Date
- March 7, 2013
- Manufacturer
- SYNTHES USA
- Product Code
- KWQ
- PMA / PMN Number
- K031276
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. 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.
Description of Event or Problem · 1
DURING A CERVICAL FUSION, LEVEL C5-6, C6-7, ONE OF THE EXPANSION TABS BROKE OFF OF THE SCREW. THE PIECE WAS RETRIEVED AND THE SCREW WAS REPLACED. NO OTHER ISSUES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 136969 | 4.0MM TI CANC EXPANSIONHEAD SCREW SELF-TAPPING 14MM | KWQ | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR |