MEDOS INTERNATIONAL SÃ RL CH MIS SINGLE INNER SETSCW; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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Model Number 186715000 |
Device Problem
Torn Material (3024)
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Patient Problem
Not Applicable (3189)
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Event Date 05/30/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported during an l4-5 lateral fusion, surgeon experienced resistance while inserting set screw.Surgeon tried backing out set screw.At this point, the expansion tip driver broke off.One piece of the tip was retrieved.The other broken piece remains implanted.Set screw was removed and found to have torn threads.Delay of 30 minutes was reported.No adverse consequence to patient.
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Search Alerts/Recalls
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