BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 9845992 · Received March 17, 2020

    Report

    Report Number
    1030489-2020-00322
    Event Type
    Malfunction
    Date Received
    March 17, 2020
    Report Date
    March 17, 2020
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    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 # 7755124, 510K # K082728, 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT FIXATION AT O-C5. PEDICLE SCREW WERE PLACED AT C2,3,4,5 AND THE OCCIPITAL PLATE WAS PLACED DUE TO C1 RUPTURE. POST-OP, THE ADJUSTABLE RODS WERE BROKEN AT THE HINGE PARTS OF BOTH SIDES AFTER OPERATION. HENCE ON AN (B)(6) 2020, A REVISION SURGERY WAS PERFORMED. IN THE REVISION SURGERY, THE REPORTED RODS WERE REPLACED WITH TWO PREBEND RODS OF G7755271. THERE WERE NO OTHER PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309031 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0584815W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention