Catalog Number 2161001 |
Device Problem
Break (1069)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 04/12/2018 |
Event Type
malfunction
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Manufacturer Narrative
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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.
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Event Description
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It was reported that the patient underwent oblique lumbar interbody fusion surgery.Intra-op, inserter tip broke during insertion.Surgeon removed inserter and was able to insert partially inserted implant in to his satisfaction.The broken tip remained in the implant.No patient complications were reported.
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Manufacturer Narrative
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Product analysis: visual review confirms the instrument is broken several threads down from the distal tip of the threaded rod.No surface defect identified that could contribute to crack propagation.Microscopic examination of the fracture surface finds a fairly brittle fracture with no indication of fatigue, with directional river lines consistent with overload.There is a slight angulation that correlates to the direction of the river lines indicating a bending moment.These observations are consistent with bend stress overload.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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