Model Number RA002-4545SL |
Device Problems
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.Report 1 of 2.
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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 as the electronic remote controller (erc) was not functional.Additionally, it was noted during surface damage grading that there was corrosion.No additional information is available.
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Manufacturer Narrative
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Corrected data: b5, d4 (model number), h6 (device codes and investigation findings codes).
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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, force testing was unable to be performed as the electronic remote controller (erc) was not functional.Additionally, it was noted during surface damage grading that there was corrosion.No additional information is available.
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Search Alerts/Recalls
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