NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE® INTRAMEDULLARY LIMB LENGTHENING ROD; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Model Number P10.7-80D305 |
Device Problem
Material Separation (1562)
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Patient Problem
No Information (3190)
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Event Type
Injury
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Manufacturer Narrative
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It was reported that the patient fell while riding his bicycle, which may have contributed to the alleged separation.The precice nail was removed and the patient was implanted with a new solid nail without incident.To date, the patient is doing fine and no negative outcomes were reported.A dhr review revealed that the nail met all of the required quality inspections, and that the device was released within specifications.
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Event Description
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A distributor reported that a patient's precice nail was removed after approximately five (5) months of implantation.The patient had achieved full lengthening of approximately 6cm; however, after viewing x-rays, the nail allegedly appeared to have separated.
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Search Alerts/Recalls
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