Catalog Number 8219500 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
Injury
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Manufacturer Narrative
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Common device name: bone fixation cerclage, sublaminar.Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that post-op, translace bands snapped at some point.Hence, on (b)(6) 2019 a revision surgery was preformed due to translace breakage.No patient complications were reported due to this event.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Patient underwent neuromuscular pediatric scoliosis correction at upper thoracic level between t4-t8.
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Search Alerts/Recalls
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