Model Number MS1-4570S |
Device Problems
Break (1069); Defective Device (2588)
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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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Event Description
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It was reported that allegedly the surgeon suspected internal pin had broken based on x-ray images.The surgeon explanted the magec rod without incident.
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Event Description
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It was reported the surgeon suspected internal pin had broken based on x-ray images.Explanted rod, and will return for evaluation.Tracking number (b)(4).
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Manufacturer Narrative
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A visual inspection of the returned rod was observed to be partially distracted with score marks on the distraction rod.An inspection of the x-ray images were reviewed confirming the pin break.A review of the lot history record for the device revealed that the device met all of the required quality inspections and that the products were released within specifications.
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Search Alerts/Recalls
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