BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1030489-2016-03607

    MDR report key: 6215013 · Received December 30, 2016

    Report

    Report Number
    1030489-2016-03607
    Event Type
    Malfunction
    Date Received
    December 30, 2016
    Date of Event
    December 6, 2016
    Report Date
    December 6, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    LEVELS IMPLANTED: T5-L1 IT WAS REPORTED THAT PATIENT WITH IDIOPATHIC SCOLIOSIS (LENKE TYPE: 1AN) UNDERWENT SPINAL CORRECTION FUSION. INTRA-OP, WHEN THE SURGEON TRIED TO PERFORM FINAL TIGHTENING AFTER CONNECTING THE TORQUE WRENCH TO THE RETAINING SCREW DRIVER T25, THE NON-BREAK OFF SET SCREW WAS STRIPPED AND COULD NOT BE TIGHTENED SMOOTHLY. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865053 NQP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR