BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 8154577 · Received December 12, 2018

    Report

    Report Number
    1030489-2018-01647
    Event Type
    Malfunction
    Date Received
    December 12, 2018
    Date of Event
    November 15, 2018
    Report Date
    December 12, 2018
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE 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 SALE IN THE US BUT A SIMILAR PART WITH CATALOGUE# 7752529 AND 510K# K082728 AND UDI# (B)(4) IS APPROVED FOR SALE IN THE US. 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 POSTERIOR CERVICAL SPINAL FUSION AT C5-C6 DUE TO C5-C6 FRACTURE. INTRA-OP, WHILE PERFORMING FINAL TIGHTENING OF MULTI-AXIAL SCREW (MAS) CROSSLINK LOCKING SCREW, THE OUTSIDE HEX PART OF THE MAS CROSSLINK SET SCREW BROKE FROM THE ROOT AND REMAINED IN THE HEAD OF THE PEDICLE SCREW. THEN, A CLIP WAS USED TO CONNECT THE ROD; AND WOUND CLOSURE WAS PERFORMED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    994667 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0562268W

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR