BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 6669142 · Received June 27, 2017

    Report

    Report Number
    1030489-2017-01628
    Event Type
    Injury
    Date Received
    June 27, 2017
    Date of Event
    May 31, 2017
    Report Date
    August 15, 2017
    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

    THIS PART IS NOT APPROVED FOR USE IN THE US, HOWEVER A LIKE DEVICE WITH PART# 6950315, 510K# K052180 AND (B)(4) IS APPROVED FOR MARKET IN THE US. (B)(4). PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO: PRODUCT ANALYSIS: VISUAL AND MICROSCOPIC EXAMINATION OF THE WITNESS MARKS ON THE PERIPHERY OF THE SET SCREW FACE AND LOCALIZED ON ONE SIDE OF THE SET SCREW CENTER NODE ARE CONSISTENT WITH INCOMPLETE TIGHTENING AND /OR ROD ANGULATION AT FINAL TIGHTENING OF THE SET SCREW.

    Description of Event or Problem · 1

    PRE-OPERATIVE DIAGNOSIS: FRACTURE DISLOCATIONS(C6-C7) PROCEDURE:PSF (POSTERIOR SPINAL FUSION) LEVELS: C6/C7 IT WAS REPORTED THAT POST-OP, WHILE REPLACING THE SCREW, IT WAS FOUND THAT THE SET SCREW IMPLANTED IN THE INITIAL SURGERY WAS LOOSE. SET SCREW WAS REMOVED. NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450549 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA H5300766

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention