BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 8779831 · Received July 11, 2019

    Report

    Report Number
    1030489-2019-00737
    Event Type
    Injury
    Date Received
    July 11, 2019
    Date of Event
    June 11, 2019
    Report Date
    February 12, 2020
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    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

    PRODUCT ANALYSIS RESULTS: OPTICAL EXAMINATION OF THE ADJACENT SURFACE IMMEDIATELY AROUND THE CRACK ORIGINATION AREA DID NOT IDENTIFY A SURFACE DEFECT WHICH COULD CONTRIBUTE TO CRACK PROPAGATION. MICROSCOPIC EXAMINATION OF FRACTURE SURFACES REVEAL A FAIRLY FLAT, QUASI-BRITTLE FRACTURE, WITH PROGRESSIVE STRIATIONS, WHICH ARE INDICATIVE OF CYCLIC FATIGUE, FOLLOWED BY ULTIMATE FAILURE OF THE IMPLANT. THE FRACTURE SURFACE MORPHOLOGY SUGGESTS THE PRIMARY MODE OF FRACTURE TO BE CYCLIC FATIGUE, WITH A LOCALIZED REGION OF ORIGIN, DIRECTION OF PROPAGATION AND SUBSEQUENT FINAL FRACTURE. THIS IS CONSISTENT WITH CYCLIC FATIGUE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 6958726, 510K # K081297, UDI# (B)(4) WAS CLEARED IN THE UNITED STATES. PRODUCT WAS NOT 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 SPINAL SURGERY DUE TO COGENITAL SCOLIOSIS. POST-OP, SCREW AT T8 WAS BROKEN. THE TIP PART OF BOTH SIDES WERE REMAINED IN THE PATIENT BODY. PATIENT UNDERWENT REVISION SURGERY DUE TO SCREW BROKEN AND A BEAK-SHAPED KYPHOSIS AT THE VERTEBRAL COLUMN RESECTION (VCR) PART. IN WHICH VERTEBRAL SCREW WAS REMOVED AND FUSION FOR EXTENDING WAS PERFORMED AT T5, 6, 7, T12 AND L1. IT IS UNKNOWN WHETHER IT IS A KYPHOSIS DUE TO A SCREW BREAKAGE OR A SCREW BREAKAGE DUE TO A KYPHOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573148 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA H10D9883

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other| R