Model Number 01-SETSCREW |
Device Problems
Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The device was not returned for evaluation as it remains implanted in the patient.As of the date of this report, a revision surgery has not been scheduled.A dhr review could not be conducted as the lot number remains unknown at this time.The date of implantation of this device is unknown.Should additional information and/or the device becomes available at a later date, this report will be updated accordingly.
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Event Description
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It was reported to rti surgical that during a patient follow-up appointment, an x-ray confirmed that a set screw had loosened post-operatively.
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Event Description
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It was reported to rti surgical that during a patient follow-up appointment, an x-ray confirmed that a set screw had loosened post-operatively.
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Manufacturer Narrative
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The device was not returned for evaluation as it remains implanted in the patient.As of the date of this report, a revision surgery has not been scheduled.A dhr review could not be conducted as the lot number remains unknown at this time.The date of implantation of this device is unknown.Should additional information and/or the device becomes available at a later date, this report will be updated accordingly.
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Search Alerts/Recalls
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