BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMA ZS SPINAL SYSTEM

    MDR report key: 6756248 · Received August 1, 2017

    Report

    Report Number
    9617297-2017-00002
    Event Type
    Injury
    Date Received
    August 1, 2017
    Date of Event
    October 10, 2016
    Report Date
    April 12, 2017
    Manufacturer
    U&I CORPORATION
    Product Code
    MNH
    PMA / PMN Number
    K020279
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BROKEN SCREW WAS NOT RETURNED. THERE WAS NO CHANGE OF DESIGN AND MATERIAL THAT MAY CONTRIBUTE TO THE BREAKAGE OF SCREW AFTER REGISTRATION OF OPTIMA POLYAXIAL SCREWS AND THE PERFORMANCE OF THEM WAS VERIFIED THROUGH TESTS DURING DEVELOPMENT. LOT, A14E131 WAS MANUFACTURED IN 2014 AND IT WAS IDENTIFIED THAT POLYAXIAL SCREW MET THE SPECIFICATION ON DRAWING. CHEMICAL COMPOSITION OF USED TITANIUM ALLOY WAS WITHIN REQUIREMENTS OF ASTM F136 STANDARD.

    Description of Event or Problem · 1

    THIS EVENT OCCURRED IN (B)(6). THE PATIENT UNDERWENT SURGERY IMPLANTING POLYAXIAL SCREW 6.0X40 AT L5/S1 TO TREAT LYRIC SPONDYLOLISTHESIS. SURGERY WAS PERFORMED ON (B)(6) 2015. AFTER SURGERY, THE PATIENT EXPERIENCED PAIN OVER A LENGTHY PERIOD. IT WAS IDENTIFIED THAT ONE SCREW BROKE AT BASE OF TULIP (HEAD OF SCREW). IT WAS THE LEFT S1 SCREW. UNABLE TO DETERMINE THE AMOUNT OF FUSION THAT HAD OCCURRED BEFORE THE SCREW BREAKS. ALL 4 SCREWS INCLUDING A BROKEN SCREW WERE REMOVED FROM THE PATIENT VIA REVISION SURGERY ON (B)(6) 2016 AND NO METAL WORK WAS REPLACED. THE PATIENT STOPPED SMOKING IN (B)(6) 2015 PRIOR TO HIS SURGERY, HE IS NOT A DIABETIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537204 OPTIMA ZS SPINAL SYSTEM SPINAL FIXATION SYSTEM MNH U&I CORPORATION A14E131

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention