NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE PLATING SYSTEM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
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Model Number LP4.5-PRF4B |
Device Problem
Corroded (1131)
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Patient Problem
Deformity/ Disfigurement (2360)
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Event Date 04/12/2021 |
Event Type
Injury
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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.If any additional information is provided, a supplemental report will be provided.
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Event Description
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Information was received that during a routine follow up appointment radiography showed a slight varus bend developing in the plate.The patient completed lengthening, however, they developed varus deformity of the right femur bone.At the time of removal, the deformity was acutely corrected.During the removal procedure a small amount of corrosion was seen at the implant's male/female junction.
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Manufacturer Narrative
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Device evaluation: upon return, visual inspection of the plate revealed the distraction rod of the plate had incurred discoloration.The reported failure of discoloration has therefore been confirmed.Additionally, the inspection revealed the distraction rod of the plate had a slight bend which has been confirmed in the reported description.At the time of removal, the surgical team suspects the plate bending could be related to abnormally tight hip abductor muscles.It was also noted by the surgery team that the bending was not severe enough to require intervention.Per reported failure functional testing was not applicable and the device met the lengthening goal.Device records review: a review of device history records for the returned unit confirmed that it met all the required quality inspections prior to release.
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Event Description
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No additional information was received.
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