MEDOS INTERNATIONAL SÃ RL CH VIPER SYSTEM POLYAXIAL WIDE LAG SCREW 5.5 8 X 80MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
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Model Number 179704880 |
Device Problem
Device Slipped (1584)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 01/01/2021 |
Event Type
Injury
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Manufacturer Narrative
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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.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2021 the primary posterior fusion was performed.On (b)(6) 2021 it was found that the rod had broken off and the screw had loosened.A revision procedure was performed on (b)(6) 2021.The broken titanium rod was replaced with a cobalt rod.Concomitant devices: unknown locking/set screw (part# unknown, lot# unknown, qty unknown).Conn o/o sd top ntch 5.5x5.5 t (part# 179771555, lot# unknown, qty two).This report is for a viper system polyaxial wide lag screw 5.5 8 x 80mm.This is report 3 of 3 for (b)(4).
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Search Alerts/Recalls
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