Catalog Number NAV6640009 |
Device Problem
Break (1069)
|
Patient Problem
Device Embedded In Tissue or Plaque (3165)
|
Event Date 01/28/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Procedure: lumbar fusion levels implanted: l4-5 it was reported that intra-op, the tip of screwdriver broke off inside the pedicle screw while inserting the screw and the broken piece could not be removed.The fragment is remaining in the patient.No patient complications were reported as a result of the event.
|
|
Manufacturer Narrative
|
Product analysis- visually confirmed that the tip of the instrument has been sheared off, consistent with interface during usage.Inspection of the shaft diameter and material hardness confirmed conformance to print specification.Optical examination of the fracture surface identified a fairly flat fracture surface and circular material displacement.The above findings are consistent with torsional overload.If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|