MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE CAN SCR 7.0X35; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
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Catalog Number 199725735S |
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 Type
Injury
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Manufacturer Narrative
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Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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 reports an event in (b)(6) as follows: it was reported that the primary tlif (l5/s1) procedure was performed on (b)(6) 2021 to treat the 5th lumbar spondylolisthesis.The procedure was completed without surgical delay.On an unknown date it was found that the cage had backed out toward the spinal canal.Two screws deployed on both sides of s1 had been quite loose/wobbly.Also, screw insertions were off the targeted lesion (the screws were supposed to be deployed at the promontorium ossis sacri area).The bone surface (where the loose screws were deployed) had a crack reaching inward.On (b)(6) 2021, the patient underwent the revision procedure.No further information is available.This report is for one (1) 5.5 exp verse can scr 7.0x35.This is report 1 of 2 for complaint (b)(4).
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Search Alerts/Recalls
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