FDA Adverse Event
Malfunction
Summary report: N
7.0MM TI USS VARIABLE AXIS SCREW 45MM THREAD LENGTH
MDR report key: 1081038
·
Received July 18, 2008
Report
- Report Number
- 2520274-2008-00055
- Event Type
- Malfunction
- Date Received
- July 18, 2008
- Date of Event
- June 21, 2008
- Report Date
- June 25, 2008
- Manufacturer
- SYNTHES (USA)
- Product Code
- KWP
- PMA / PMN Number
- K002517
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE IS NOT BEING EXPLANTED. SYNTHES IS UNABLE TO DETERMINE THE MANUFACTURING SITE WITHOUT A LOT NUMBER: SYNTHES IS UNABLE TO DETERMINE THE MANUFACTURING DATE WITHOUT A NUMBER. NO INVESTIGATION COULD BE PERFORMED, NO CONCLUSION DRAWN, AS NO DEVICE WAS RETURNED.
Description of Event or Problem · 1
PATIENT UNDERWENT A L5 POSTERIOR LATERAL FUSION. A POST OP X-RAY REVEALED THE TOP OF THE SCREW HEAD BECAME DETACHED FROM THE CONSTRUCT. SURGEON IS NOT PLANNING A REVISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 7.0MM TI USS VARIABLE AXIS SCREW 45MM THREAD LENGTH | VARIABLE AXIS SCREWS | KWP | SYNTHES (USA) | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR |