Catalog Number 897-405 |
Device Problem
Break (1069)
|
Patient Problem
Device Embedded In Tissue or Plaque (3165)
|
Event Date 07/16/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
X-ray review results: intra-op film for l5 s1 alif show a retained fragment of one of the stability pins.It is unknown if it was able to be removed.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 anterior lumbar interbody fusion (alif) at l5-s1 due to degenerative disc.Intra-op, stability pin was broken off during retraction and point of stability pin stuck at l5-s1 right side of the patient.Fragment of the instrument remaining in the patient body.No sharp edges pointing true the bone, so risk to damage soft tissue.No revision surgery is planned to remove the broken part from the patient surgery.No patient's complications were reported as a results of this event.
|
|
Manufacturer Narrative
|
Product analysis results: visual inspection confirmed the pin was returned with approximately 14mm of the tip missing.A microscopic review of the fracture surface reveals a fairly steep angulation with a sheer lip at the end of the fracture.There did not appear to be any abnormalities at the crack initiation point that would have lead to this failure.The diameter of the shaft meets print specification.This type of damage is consistent with bend stress overload.If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|