Model Number P10.7-50D230 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Non-union Bone Fracture (2369); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Manufacturer Narrative
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The device has not been returned for evaluation as it remains in-situ.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 the patient presented with non-union of the osteotomy and lengthening site and severe muscle atrophy.The nail remains implanted.
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Manufacturer Narrative
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A review of the device history records (dhr) confirmed the device met all quality inspections and specifications prior to release.
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Event Description
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Additional information has been provided.
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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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The unit was not returned to nuvasive for direct investigation.Evaluation of the provided radiographic pictures showed that the nail and screws were intact and that there was no issue was found with the nail.Based on the obtained information, the left femoral was lengthening without any abnormal radiographic findings.There was also no muscle atrophy visible on the provided x-ray.The reported failure was unable to be confirmed.The unit¿s work order was reviewed and confirmed that the device passed all inspections per the acceptance testing.
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Search Alerts/Recalls
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