SYNTHES USA TI MATRIX TOP LOADING POLYAXIAL HEAD; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
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Catalog Number 04.632.001S |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Patient id, date of birth and weight are not available for reporting.Date of event is unknown.Additional device product code mnh, mni, kwq, kwp.(b)(4).Device is not expected to be returned for manufacturer review/investigation.Reporter contact number (b)(6).(b)(4).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.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 europe reports an event in (b)(6) as follow: it was reported that on (b)(6) 2016, the patient underwent initial spinal fusion surgery due to lumbar spinal canal stenosis and degenerated scoliosis.At that time, six (6) bone-screws and six (6) screw-heads were used to fix at l3-l5.After the surgery on unknown date, patient suffered from the adjacent intervertebral disc disorder.The revision surgery was performed on (b)(6) 2016, and the initial implanted screw-heads were removed, and decompression was performed.Then, additional screws were implanted at l2-s1.The surgeon commented that the cause of the disc order was not related to the product defects.The disc order was easy to occur naturally due to post spinal fusion.The revision surgery was completed successfully, and the patient's condition was reported as stable.During the revision surgery, an instrument problem occurred.Events occurred during revision procedure are captured under (b)(4).This report is for one (1) ti matrix top loading polyaxial head.This is report 7 of 12 for (b)(4).
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Manufacturer Narrative
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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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The surgeon commented the cause of the adjacent intervertebral disc disorder was not related to the products defects.Patient outcome reported as under observation.
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Search Alerts/Recalls
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