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Model Number TR500000 |
Device Problems
Break (1069); Migration or Expulsion of Device (1395)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/26/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.
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Event Description
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It was reported that the patient underwent a surgical procedure with a hunter tendon rod being implanted.The surgeon took x-rays 9 days post-op and the rod was intact and where it should be.Allegedly, 3 months post-op the surgeon again took x-rays in preparation for the second phase of the surgery.The surgeon noticed the rod had broken with approximately 1 cm still attached distally and the other portion of the rod had migrated 2 cm.
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Search Alerts/Recalls
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