MEDOS INTERNATIONAL SÃ RL CH VIPER TI SAI POLY 9X90MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
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Model Number 179704990 |
Device Problem
Break (1069)
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Patient Problem
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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Product complaint # (b)(4).Additional product code: kwp; kwq; mnh; mni.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that on an unknown date, the patient had a surgery for posterior spinal fusion in (b)(6) of 2020.At a follow up appointment in (b)(6) of 2020, xray images showed that the set screw had loosened from the sai screws bilaterally and the rod had loosened due to head splay.The s1 and l5 screws had fractured at the neck of the screw just below the tulip.It is unknown if fragments were generated.The patient did not achieve a fusion below l5 due to this hardware failure.Procedure outcome is unknown.This complaint involves five (5) devices.This report is for (1) viper ti sai poly 9x90 mm.This report is 2 of 5 for (b)(4).
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Search Alerts/Recalls
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