BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 7174305 · Received January 9, 2018

    Report

    Report Number
    1030489-2018-00024
    Event Type
    Malfunction
    Date Received
    January 9, 2018
    Date of Event
    December 19, 2017
    Report Date
    May 11, 2018
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE US, HOWEVER A LIKE DEVICE WITH PART# 7752500, 510K#K062879 AND (B)(4) IS AVAILABLE FOR THE MARKET. 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: VISUALLY CONFIRMED THE MAS CONNECTOR IS BROKEN AT APPROXIMATELY THE BASE OF THE CONNECTOR HEX HEAD. THE BOTTOM PORTION OF THE IMPLANT WAS MISSING AND NOT RETURNED FOR ANALYSIS. MICROSCOPIC EXAMINATION OF THE THREAD FORM DID NOT IDENTIFY THREAD DAMAGE ON THE RETURNED PORTION OF THE IMPLANT. MICROSCOPIC EXAMINATION OF THE FRACTURE SURFACE APPEARS TO EMANATE FROM THE ROOT OF THE INTERNAL THREAD TOOTH OUTWARD, IS ROUGHLY PARALLEL WITH THE TOOTH ANGULATION, WITH EVIDENCE OF LINEAR SHEAR LINES ON THE FRACTURE SURFACE. 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

    IT WAS REPORTED THAT PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH CERVICAL FRACTURE AND UNDERWENT POSTERIOR CERVICAL FUSION AT C1-2. DURING SURGERY, THE SET SCREW BROKE WHILE PERFORMING THE FINAL TIGHTENING. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT OF THE BROKEN PRODUCT REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20804 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0531235W

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR