Model Number MS1-4590S |
Device Problems
Defective Device (2588); Appropriate Term/Code Not Available (3191)
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Patient Problems
Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)
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Event Date 02/20/2019 |
Event Type
Injury
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Manufacturer Narrative
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No product has been returned for investigation nor were x-rays provided to confirm the alleged event.
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Event Description
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Received a report that indicated possible non distraction due to pin failure.Patient underwent a revision procedure on (b)(6) 2019 with no reported issues.
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Event Description
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Possible failure of internal distraction mechanism, significant amount of black debris in surrounding tissue.
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Manufacturer Narrative
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A visual inspection of the returned magec rods revealed to be partially distracted with score marks on the distraction rod.X-ray images revealed that both rods had broken locking pins.A device history record review revealed that the magec rods met all the required quality inspections and was released within specifications.
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Search Alerts/Recalls
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