SYNTHES GMBH UNK - MONO/POLYAXIAL SCREWS: USS; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
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Device Problem
Device-Device Incompatibility (2919)
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Patient Problems
Failure of Implant (1924); No Code Available (3191)
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Event Date 10/13/2020 |
Event Type
Injury
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Manufacturer Narrative
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This report is for an unknown mono/polyaxial screw: uss/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(b)(4).Device was used for treatment, not diagnosis.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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Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, during an unknown procedure, when the surgeon attempted to complete the final tightening of the nut, the screw would not tighten which caused the poly head not to fix as intended.No further information provided.Concomitant devices reported: unknown sleeve (part# unknown, lot# unknown, quantity 1).Unknown rod (part# unknown, lot# unknown, quantity 1).Unknown insertion instrument (part# unknown, lot# unknown, quantity 1).This report is for one (1) unknown mono/polyaxial screws: uss.This is report 2 of 3 for (b)(4).
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Event Description
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Concomitant devices reported: unknown sleeve (part# unknown, lot# unknown, quantity 1), unknown rod (part# unknown, lot# unknown, quantity 1), unknown insertion instrument (part# unknown, lot# unknown, quantity 1).
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