Model Number BT115-10SJ360-7 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Unspecified Infection (1930)
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Event Type
Injury
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Manufacturer Narrative
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No product has been returned for evaluation.Radiographs provided confirmed the alleged event.No root cause can be confirmed at this time.
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Event Description
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Information was received that a removal surgery was completed in (b)(6) of 2019.As per reporter, the patient developed an infection (non-implant related) and the surgeon needed to remove the nail and put on external fixation.A few days later, for follow up of the external fixation pins, it was observed on x-rays that the bone transport nail had disassociated during the removal process and some of the components were left behind in the patient.
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Manufacturer Narrative
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The nail was received for visual and functional testing.Visual inspection revealed scratches on the housing tube and a gap between the end cap and housing tube.The nail was functionally tested and was able to retract and distract.Force testing could not be performed due to the gap between the end cap and housing tube.An internal investigation revealed that the retention of the distal plug component into the housing tube was not sufficient to withstand the impaction forces placed on the implant during implant removal.In order to mitigate this failure mode, nuvasive specialized orthhpedics (nso) developed a single-use instrument to be used during removal surgery.The single-use instrument is utilized after removal of the distal locking screws by placing a plug into the distal hole in order to retain the distal plug component of the implant.
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Search Alerts/Recalls
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