FDA Adverse Event
Malfunction
Summary report: N
2520274-2013-01569
MDR report key: 3012040
·
Received March 20, 2013
Report
- Report Number
- 2520274-2013-01569
- Event Type
- Malfunction
- Date Received
- March 20, 2013
- Date of Event
- February 22, 2013
- Report Date
- February 25, 2013
- Manufacturer
- SYNTHES USA
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. 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. PLACEHOLDER.
Description of Event or Problem · 1
DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: REPORTEDLY THE MATRIX PEDICLE SCREW AND THE MATRIX DISTRACTOR TIP FOR BONE SCREWS BECAME CROSS THREADED. SUBSEQUENTLY, THE DEVICES BECAME MISALIGNED CAUSING SHREDDED DAMAGE TO BOTH THE SCREW AND DISTRACTOR TIP. THIS REPORT IS FOR AN UNKNOWN MATRIX DISTRACTOR TIP. THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 115425 | LXH | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |