BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 6455712 · Received April 3, 2017

    Report

    Report Number
    1030489-2017-00741
    Event Type
    Malfunction
    Date Received
    April 3, 2017
    Date of Event
    March 10, 2017
    Report Date
    March 10, 2017
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    PMA / PMN Number
    REFER H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 6950315, 510K # K052180 AND UDI# (B)(4) WAS CLEARED IN THE UNITED STATES. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED 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

    IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT PRESENTED WITH PRE-OPERATIVE DIAGNOSIS: C7 FRACTURE-DISLOCATION. FOR WHICH PATIENT UNDERWENT POSTERIOR FUSION AT LEVELS C2-T3. INTRA-OP, DURING C2 SET SCREW INSERTION OVER A ROD PUSHER AND A COUNTER TORQUE, THE COUNTER TORQUE SLIPPED AND A QUICK RELEASE SELF HOLDING MOVED TOWARD THE ANTERIOR OF C2 RIGHT SIDE. IT MOVED UNTIL THE ANTERIOR WALL OF C2 VERTEBRAL BODY AND AS A RESULT, THE SET SCREW WAS LEFT THERE. AFTER THAT IT WAS REMOVED USING THE FACILITY-OWNED NUCLEUS PULPOSUS FORCEPS. NO PATIENT COMPLICATIONS WERE REPORTED. SET SCREW WAS DISCARDED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237670 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1