FDA Adverse Event
Malfunction
Summary report: N
3.7MM TI CERV SPN SCR SLF-DRLGVARIABLE ANGLE 16MM-STERILE
MDR report key: 2960642
·
Received February 14, 2013
Report
- Report Number
- 2520274-2013-00919
- Event Type
- Malfunction
- Date Received
- February 14, 2013
- Date of Event
- December 17, 2010
- Report Date
- December 17, 2010
- Manufacturer
- SYNTHES
- Product Code
- ODP
- PMA / PMN Number
- K121852
- 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 A PIECE CAME OFF DURING INSERTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 64160 | 3.7MM TI CERV SPN SCR SLF-DRLGVARIABLE ANGLE 16MM-STERILE | 3.7MM TI CERV SPN SCR SLF | ODP | SYNTHES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |