BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERVICAL PLATE VARIABLE SELF-DRILLING SCREW DIAM. 4X16MM (2X)

    MDR report key: 5523444 · Received March 24, 2016

    Report

    Report Number
    3005180920-2016-00113
    Event Type
    Injury
    Date Received
    March 24, 2016
    Date of Event
    February 25, 2016
    Report Date
    May 27, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWQ
    PMA / PMN Number
    K140361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE (B)(4) PROJECT MANAGER PERFORMED A PRELIMINARY INVESTIGATION AND COMMENTED AS FOLLOWS: BASED ON THE EVENT DESCRIPTION, IT APPEARS THAT THE SCREW-SCREWDRIVER INTERFACE FAILED IN THE ATTEMPT TO CORRECT THE WRONG TRAJECTORY OF THE SCREW, WHICH WAS LIKELY TOO SLOPED AND THEREFORE TO DIFFICULT TO ENTER IN THE PLATE HOLE. THE SCREWDRIVER-SCREW INTERFACE OF SCREWDRIVERS IN FORCE IS DESIGNED WITH MINOR TOGGLE. HOWEVER, SUCH A DESIGN IS NOT AIMED FOR THE ADJUSTMENT OF THE SCREW TRAJECTORY. THIS IS ASSUMED TO BE THE REASON OF THE FREQUENT INTERFACE FAILURE. THE (B)(4) PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE RETRIEVED INSTRUMENT AND COMMENTED AS FOLLOWS: DURING THE VISUAL INSPECTION OF THE DRIVER, IT WAS OBSERVED THAT ONE OUT OF FOUR PRONGS WAS DEFORMED AND ANOTHER ONE WAS FULLY BROKEN. THE TWO REMAINING ONES WERE STILL INTACT. IT MAY BE SUPPOSED THAT THE TORSIONAL FORCE ON THE DRIVER-SCREW INTERFACE WAS NOT EQUALLY DISTRIBUTED ON THE FOUR PRONGS, BUT CONCENTRATED ON ONE OR TWO PRONGS ONLY BECAUSE OF MISALIGNMENT. ON 24 MAY 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON THE SAME DATE THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 21 MARCH 2016. LOT 141365: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 OCTOBER 2014. EXPIRATION DATE: 2019-06-30. 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 SELF RETAINING SCREWDRIVER, CODE 03.70.10.0001, LOT. 1316455A (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 OCTOBER 2015. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OTHER SIMILAR EVENTS HAVE BEEN ALREADY REPORTED ON ITEMS OF THE SAME LOT. NOT YET RECEIVED.

    Description of Event or Problem · 1

    THE SURGEON WAS PLACING HIS C7 SCREW ON THE LEFT SIDE OF THE PATIENT AND SAW THIS WENT NOT IN THE GOOD DIRECTION DUE TO THE TOGGLING. THE SCREW WAS PAST HALF, HE REMOVED THE SCREW AND WHEN THE REPORTER WANTED TO ENGAGE THE SCREW, HE SAW THAT THE LIPS OF THE IMPLANT AND THE SCREWDRIVER WHERE BEND. BECAUSE OF THIS THE REPORTER ASKED 2 NEW SCREWS. A BIT TIME HAD BEEN LOST DUE OF THE OPENING OF THE NEW SCREW. IN THE END THE OPERATION WENT WELL. THE RETRIEVED ITEMS WILL BE RETURNED TO MEDACTA INTERNATIONAL SA:

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180533 CERVICAL PLATE VARIABLE SELF-DRILLING SCREW DIAM. 4X16MM (2X) SELF-DRILLING SCREW KWQ MEDACTA INTERNATIONAL SA 141365

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other