NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE® SYSTEM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Model Number P10.7-80D305 |
Device Problems
Crack (1135); Fracture (1260)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 05/10/2022 |
Event Type
Injury
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Manufacturer Narrative
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The device has not been returned for evaluation at this time.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.
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Event Description
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Information was received that during a physiotherapy session, the nail's housing tube cracked at the junction of the housing tube and distraction rod, and the crown of the nail fractured.As per the reporter, there was loss of rotational stability.The nail was removed; there was no further adverse patient impact reported.No additional information is available.
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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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Device records review: a review of the device history records (dhr) confirmed the device met all quality inspections and specifications prior to release.Device evaluation: upon return, visual inspection of the returned precice nail revealed that the housing tube had cracks at the anti-rotation lug or the crown region.The anti-rotation lug was broken in two pieces.X-ray images of the internal components confirmed the broken anti-rotation lug.Loss of distraction/rotational stability is likely due to broken anti-rotation lug.The work order was reviewed and confirmed the device passed all inspections per the acceptance tests.The manufacturing x-ray image showed the anti-rotation lug (crown) was seated properly in the housing body.Based on the provided information and the type of observed breakage, it is likely that the nail broke due to stress generated from weight bearing activities.Labeling: per the precice instructions for use, ¿the precice nail cannot withstand the stresses of full weight bearing.Patients should utilize external support, and/or restrict activities as directed by the physician until consolidation occurs¿.
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Search Alerts/Recalls
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