BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 8483056 · Received April 4, 2019

    Report

    Report Number
    1030489-2019-00389
    Event Type
    Malfunction
    Date Received
    April 4, 2019
    Date of Event
    November 30, 2018
    Report Date
    April 4, 2019
    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 PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG# 7753500,510K # K082728 AND UDI (B)(4) IS APPROVED FOR SALE IN US. PRODUCT ANALYSIS RESULT: VISUAL MICROSCOPIC VISUALLY CONFIRMED THE MAS CONNECTOR IS BROKEN AT APPROXIMATELY THE BASE OF THE CONNECTOR HEX HEAD. THE BOTTOM THREADED PORTION OF THE IMPLANT WAS NOT RETURNED FOR ANALYSIS. MICROSCOPIC EXAMINATION OF THE THREAD FORM DID NOT IDENTIFY THREAD DAMAGE ON THE RETURNED PORTION OF THE IMPLANT. THE LOCATION OF THE FRACTURE AT THE BASE OF THE CONNECTOR HEAD, THE FRACTURE SURFACE ANGULATION RELATIVE TO THE THREAD AXIS, ABSENCE OF THREAD DAMAGE AND DIRECTION OF SHEAR LINES ARE CONSISTENT WITH TORSIONAL OVERLOAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PRE-OP DIAGNOSIS: CSM(CERVICAL SPONDYLOTIC MYELOPATHY) PROCEDURE:POSTERIOR CERVICAL DECOMPRESSION FUSION LEVELS IMPLANTED: C3 IT WAS REPORTED THAT INTRA-OP, THE PROJECTION PART OF THE MAS SET SCREW BROKE OFF. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF EVENT. THERE NO DELAY IN PROCEDURE TIME AS A RESULT OF EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278203 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0657179W

    Patients

    Seq Age Sex Outcome Treatment
    1