Model Number RA002-4545SL70 |
Device Problems
Break (1069); Corroded (1131); Mechanical Jam (2983)
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Patient Problem
Failure of Implant (1924)
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Event Type
malfunction
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Manufacturer Narrative
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The device has not been returned for evaluation.The evaluation was performed by the london implant retrieval center (lirc).The root cause is unable to be determined at this time.A review of the device history records (dhr) confirmed the device met all quality inspections and specifications prior to release.If any additional information is provided, a supplemental report will be submitted.
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Event Description
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An investigation report from an implant retrieval center was received and reported that during examination, the rod would not distract and force testing was unable to be performed.Additionally, it was noted during surface damage grading that there was corrosion.It was reported that the rod was removed due to a broken rod at the solid section.There was no adverse patient or user impact associated with this report.No additional information is available.
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Manufacturer Narrative
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The device was not returned to nuvasive for evaluation, however, the provided patient x-rays were reviewed and confirmed a solid section break.Without the return of the device, the root cause is unable to be determined.
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Event Description
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No additional information has been provided.
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Search Alerts/Recalls
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