Model Number MC2-5070R |
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 (b)(6).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 2 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, force testing was unable to be performed.Additionally, it was noted during surface damage grading that there was galling and corrosion.High energy x-ray evaluation showed evidence of internal screw fracture.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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Corrected data: d4 (lot number).
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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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