MEDOS INTERNATIONAL SÃ RL CH UNIPLATE SLFDRLNG SCW,12MM 2PK; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
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Catalog Number 189707012S2P |
Device Problem
Device Slipped (1584)
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Patient Problems
Failure of Implant (1924); Unspecified Tissue Injury (4559)
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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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It was reported that the patients hardware become loose due to poor bone quality and non compliance.Patient is status post 3 level anterior cervical discectomy and fusion (acdf).Initial procedure was performed on (b)(6), 2021.Patient hardware was explanted on (b)(6), 2021.Patient and procedure outcome were unknown.No further information provided.This report is for one (1) uniplate slfdrlng scw,12mm 2pk.This is report 1 of 6 for (b)(4).
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Search Alerts/Recalls
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