Device product
Solitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b) 14-531594 Spring-Loaded Drill/Awl Sleeve Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.
Z-0874-2015
Product summary
- Firm
- Ebi, Llc
- Event
- Event 69981
- Status
- Terminated
- Classification
- Class II
- Quantity
- 193 units
- Official record key
device-enforcement:Z-0874-2015
Official wording
Reason: A design deficiency was discovered whereby the Drill/Awl Sleeve and Spring-Loaded Drill/Awl Sleeve instruments ( the Sleeves ) allow the mating Drill and Awl instruments to penetrate 1.0 mm beyond their intended depths during screw hole preparation.
Code information: Part number 14-531593 Part number 14-531594 Catalog number Lot Number 14-531593 N23597 14-531594 N23599
Distribution pattern: US Nationwide Distribution.
Derived failure modes
-
Unknown
A design deficiency was discovered whereby the Drill/Awl Sleeve and Spring-Loaded Drill/Awl Sleeve instruments ( the Sleeves ) allow the mating Drill and Awl instruments to penetrate 1.0 mm beyond their intended depths during screw hole preparation.