FDA Adverse Event
Malfunction
Summary report: N
7.0MM TI PANGEA(TM) POLYAXIAL SCR DUAL CORE/40MM THRD LGTH
MDR report key: 2954939
·
Received February 11, 2013
Report
- Report Number
- 2520274-2013-00855
- Event Type
- Malfunction
- Date Received
- February 11, 2013
- Date of Event
- December 9, 2009
- Report Date
- December 17, 2009
- Manufacturer
- SYNTHES
- Product Code
- KWP
- PMA / PMN Number
- K082572
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT. (B)(4). THIS INDIVIDUAL ADVERSE EVENT REPORT IS BEING MADE IN ACCORDANCE WITH THE SYNTHES MDR EXEMPTION REQUEST DATED (B)(4) 2011. AS NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION, NO FURTHER INFORMATION IS AVAILABLE ON THIS EVENT. NO FURTHER INVESTIGATION CAN BE PERFORMED.
Description of Event or Problem · 1
(B)(6) REPORTED THE INNER GOLDEN RING BROKE AFTER USING THE RE-MOBILIZER TO REMOBILISE THE SCREW HEAD. THE FRAGMENT WAS NOT AVAILABLE FOR INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 58850 | 7.0MM TI PANGEA(TM) POLYAXIAL SCR DUAL CORE/40MM THRD LGTH | 7.0MM TI PANGEA(TM) POLYAXIAL | KWP | SYNTHES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |