Catalog Number 7540020 |
Device Problems
Failure to Align (2522); Material Deformation (2976)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/07/2019 |
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 was undergoing a surgery for spinal degeneration.Intra-op, thread of the product was damaged and its nut was sliding.The product was then removed completely.There were no patient symptoms or complications as a result of this event.
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Manufacturer Narrative
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Product analysis: visual and macroscopic examination revealed thread crest and flank damage; this damage appears to have initiated at the start of the thread, and is consistent around the damaged portion of the thread.Functional evaluation found the set screw unable to be fully engaged into a sample mas head the above observations are consistent with misalignment of the mas and set screw threads during construct assembly.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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