Catalog Number X0912057 |
Device Problem
Break (1069)
|
Patient Problems
No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
|
Event Date 07/20/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
Product was not 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
|
It was reported that the patient underwent transforaminal lumbar interbody fusion at l4-s1.During surgery, the tip of the inserter was broken and was still inside the cage.Fragments of the broken part remained inside the patient.No patient complications were reported as a result of the event.
|
|
Manufacturer Narrative
|
Product analysis: visual and microscopic examination identified that part of the tip of the inserter is sheared off and missing.This damage is consistent with overload through non-parallel pressure put on the handle.This is consistent with bend stress overload.: image review: intra-operative images from l4-s1 fusion provided.At l5-s1 there is a metallic fragment next the interbody graft which by report is the tip of the inserter.This fracture usually happened under conditions of excessive mallet or oblique torsional force applied to the inserter when placing the graft.If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|