BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 8183869 · Received December 20, 2018

    Report

    Report Number
    1030489-2018-01689
    Event Type
    Malfunction
    Date Received
    December 20, 2018
    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. 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.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS RESULT: VISUAL MICROSCOPIC VISUAL AND MICROSCOPIC EXAMINATION DID NOT REVEAL ANY CRACKS, FRACTURES OR ANY EVIDENCE THAT WOULD SUGGEST A DEFECT IN MANUFACTURING OR PROCESSING. NO FAULT FOUND. THE IMPLANT APPEARS TO BE CAPABLE OF PERFORMING ITS INTENDED FUNCTION. 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. THE BROKEN PART REMAINED IN THE SCREW HEAD. 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
    1024668 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0657179W

    Patients

    Seq Age Sex Outcome Treatment
    1