Model Number RA002-5555SL |
Device Problems
Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Metal Related Pathology (4530)
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Event Date 09/14/2023 |
Event Type
Injury
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Event Description
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Information was received that upon removal it was noted that the patient had developed metallosis which was debrided during the procedure.There were no complication due to the observed metallosis.No additional information has been provided.
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Manufacturer Narrative
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The device has not been returned for evaluation.The root cause is unable to be determined at this time.A review of the device history record (dhr) confirmed the device met all required quality inspections and specifications prior to release.If any additional information is provided, a supplemental report will be submitted.
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Manufacturer Narrative
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Device evaluation: the rod has been returned to nuvasive for evaluation.Initial visual inspection indicates that there was some scoring marks on the distraction rod consistent with incremental distraction and some black debris on the housing body.In-house x-ray were conducted and determined that the device had no disparities internally.Functional testing was performed, however, the rod was unable to be distracted using a manual distractor as well as the fast distractor.The rod was then sectioned, and the o-ring was examined.The o-ring was found torn in the housing groove and was removed in pieces.No patient x-rays or lab results were provided, therefore, the reported metallosis could not be confirmed.However, wear debris was confirmed visually as it was found on the device upon return.The black debris that was found is likely titanium debris caused by friction during use.
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Event Description
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No additional information has been provided.
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Manufacturer Narrative
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Corrected data: h6 (health effect - impact code and device code).
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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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