BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERVICAL PLATE FIXED SELF-TAPPING SCREW DIAM. 4X14MM (2X)

    MDR report key: 7872474 · Received September 13, 2018

    Report

    Report Number
    3005180920-2018-00674
    Event Type
    Injury
    Date Received
    September 13, 2018
    Date of Event
    August 14, 2018
    Report Date
    September 13, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWQ
    UDI-DI
    07630030841323
    PMA / PMN Number
    K140361
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 12 SEPTEMBER 2018; LOT 141343: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 OCTOBER 2014. EXPIRATION DATE: 2022-12-18; NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT OTHERS PIECES INVOLVED: CERVICAL PLATE VARIABLE SELF-TAPPING SCREW DIAM. 4X14MM (2X) REFERENCE 03.70.055 (K140361); LOT 1620195: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 JUNE 2016. EXPIRATION DATE: 2021-05-26; NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT CERVICAL PLATE VARIABLE SELF-TAPPING SCREW DIAM. 4X14MM (2X) REFERENCE 03.70.055 (K140361); LOT 1520525: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 4 FEBRUARY 2016. EXPIRATION DATE: 2021-01-19 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH A SIMILAR REPORTED EVENT. CERVICAL PLATE VARIABLE SELF-TAPPING SCREW DIAM. 4X14MM (2X) REFERENCE 03.70.055 (K140361); LOT 1620085: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 JULY 2016. EXPIRATION DATE: 2021-07-12; NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH A SIMILAR REPORTED EVENT CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS (B)(4) ON 11 SEPTEMBER 2018; 1.5 YEARS AFTER MULTI-LEVEL CERVICAL FUSION SURGERY, ATTEMPTED USING ANTERIOR PLATE AND 3 INTERBODY CAGES, THE SCREWS HOLDING THE PLATE WERE FOUND BROKEN AND THE PATIENT FOUND SYMPTOMATIC. IT IS RATHER UNUSUAL THAT SO MANY SCREWS BREAK TOGETHER, BUT IT'S ALSO CONCEIVABLE THAT THEY BROKE IN SUCCESSION. ALSO, IN SPITE OF THE TIME ELAPSED, THE INTERBODY CAGES WERE APPARENTLY NOT ENOUGH TO HOLD THE SEGMENTS IN PLACE. WE HAVE NO REPORT OF TRAUMATIC EVENTS OR EXCEPTIONAL SITUATIONS THAT MAY HAVE LED TO THIS CONDITION. FROM THE XRAY SUPPLIED, NO ANOMALY IN DEVICE PLACEMENT CAN BE RECOGNIZED THAT MAY HAVE LED TO MULTIPLE FRACTURES AND INSTABILITY. HOWEVER, IF FUSION DOES NOT OCCUR, IT IS POSSIBLE THAT THE SCREWS WILL EVENTUALLY BREAK BECAUSE THEY CANNOT BE MADE LARGE ENOUGH TO SUSTAIN CYCLIC LOAD INDEFINITELY. WE ARE UNABLE TO DETERMINE THE CLINICAL CAUSE WHICH LED TO REOPERATION.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THAT THE SCREWS HAD BROKEN IN THE PATIENT THE SURGEON REMOVED THE SCREWS, AND THE PLATE AND FUSED THE POSTERIOR C3-C6. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714550 CERVICAL PLATE FIXED SELF-TAPPING SCREW DIAM. 4X14MM (2X) FIXED SELF TAPPING SCREW KWQ MEDACTA INTERNATIONAL SA 141343 07630030841323

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention