Device product
Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01-1102-1000) is utilized to allow the surgeon to apply a recommended tension to the band and hold it in place during spine manipulation and set screw tightening.
Z-2321-2017
Product summary
- Event
- Event 77270
- Status
- Terminated
- Classification
- Class II
- Quantity
- 82
- Official record key
device-enforcement:Z-2321-2017
Official wording
Reason: Over-tensioning of the band resulting in damage to the band causing it to rupture
Code information: All lots Product Number: 01-1102-1000
Distribution pattern: Worldwide Distribution-US distribution to: MO, NY, KY, FL, NC and OH; and countries of: AUSTRALIA, FRANCE and SPAIN.
Derived failure modes
-
Unknown
Over-tensioning of the band resulting in damage to the band causing it to rupture