FDA Adverse Event
Malfunction
Summary report: N
TI N-FLEX ROD 150MM-STERILE
MDR report key: 1933208
·
Received December 14, 2010
Report
- Report Number
- 1719045-2010-00363
- Event Type
- Malfunction
- Date Received
- December 14, 2010
- Date of Event
- December 29, 2010
- Report Date
- November 29, 2010
- Manufacturer
- SYNTHES MONUMENT
- Product Code
- NQP
- PMA / PMN Number
- K072685
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SUBJECT DEVICE HAS NOT BEEN EXPLANTED. SYNTHES IS UNABLE TO PROVIDE THE DATE OF MFR AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.
Description of Event or Problem · 1
SYNTHES WAS INFORMED THAT A N-FLEX ROD WAS DISCOVERED BROKEN; THE PT WAS ASYMPTOMATIC. THE SURGEON IS NOT REMOVING THE HARDWARE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TI N-FLEX ROD 150MM-STERILE | N-FLEX ROD | NQP | SYNTHES MONUMENT | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | SCREW |