Catalog Number 54740015545 |
Device Problem
Device Damaged by Another Device (2915)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/25/2017 |
Event Type
malfunction
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Manufacturer Narrative
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This part is not approved for use in the united states; however a like device catalog # 54840015545, 510k #k091974 and (b)(4) was cleared in the united states.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.
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Event Description
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Pre-operative diagnosis :l1 burst fracture levels :t11-l2 it was reported that during surgery, there were metal fragments around the right side of l2 screw in the surgical field after final tightening.The screw head was widened due to cross thread, the screw was removed.There was a delay of less than 60 minutes in overall procedural time.No fragments of the screw were remaining in the patient.No patient complications were reported.
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Manufacturer Narrative
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Product analysis: the head of the mas bone screw is splayed open slightly.This type of damage would have occurred because the set screw was misaligned.Once the splaying occurred the set screw would not torque down properly and could possibly jump threads.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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