Device product
Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion - 2.5mm Drill Bit, graduated 12mm - 26mm adjustable depth, Part Number 03.613.011. Synthes Vectra System, Synthes Vectra-One System and Synthes Vectra-T System is intended for anterior plate and screw fixation of the cervical spine (C2-C7).
Z-0781-2013
Product summary
- Event
- Event 62943
- Status
- Terminated
- Classification
- Class II
- Quantity
- 63
- Official record key
device-enforcement:Z-0781-2013
Official wording
Reason: Although the reported incidence is low, there is the potential for the drill stop to slip on the drill bit resulting in an adverse event.
Code information: 2.5mm Drill Bit, graduated 12mm - 26mm adjustable depth, Part Number 03.613.011 - Lots 5443576, 5522810, 5537042, 5557902
Distribution pattern: Nationwide Distribution-including Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY.
Derived failure modes
-
Unknown
Although the reported incidence is low, there is the potential for the drill stop to slip on the drill bit resulting in an adverse event.