FDA Adverse Event
Malfunction
Summary report: N
6.0MM TI CANN PANGEA POLYAXIALSCR DUAL CORE/40MM THRD LENGTH
MDR report key: 2960134
·
Received February 13, 2013
Report
- Report Number
- 2520274-2013-00887
- Event Type
- Malfunction
- Date Received
- February 13, 2013
- Date of Event
- September 9, 2010
- Report Date
- September 22, 2010
- 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. \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 DURING THE INSERTION OF PANGEA SCREWS, THEY DISASSEMBLED IN 4 PARTS. THIS EVENT HAPPENED WITH THREE SCREWS IN THE SAME SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 62376 | 6.0MM TI CANN PANGEA POLYAXIALSCR DUAL CORE/40MM THRD LENGTH | 6.0MM TI CANN PANGEA | KWP | SYNTHES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |