BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUINTEX SEMICONSTRAINED SCREW 4.0X14MM

    MDR report key: 8525174 · Received April 17, 2019

    Report

    Report Number
    9610612-2019-00258
    Event Type
    Injury
    Date Received
    April 17, 2019
    Date of Event
    March 19, 2019
    Report Date
    April 21, 2019
    Manufacturer
    AESCULAP AG
    Product Code
    KWQ
    PMA / PMN Number
    K100243
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER, REGISTRATION NO. 9610612). EXEMPTION NUMBER: E2014018 INVESTIGATION: DURING A VISUAL INSPECTION WE FOUND, THAT THE MAJOR PART OF THE SCREW-THREAD IS SHEARED OFF. THE ENCLOSED SHAVING IS ONLY A PART OF THE SHEARED OFF THREAD. THE OTHER PARTS WERE NOT RECEIVED. BATCH HISTORY REVIEW: THE MANUFACTURING DOCUMENTS HAVE BEEN CHECKED AND FOUND TO BE ACCORDING TO SPECIFICATION VALID DURING THE TIME OF PRODUCTION. THERE ARE NO FURTHER COMPLAINS WITH THIS BATCH AND ERROR PATTERN AT HAND. CONCLUSION AND ROOT CAUSE: THE ROOT CAUSE FOR THE PROBLEM IS MOST PROBABLY USAGE RELATED. RATIONALE: WITHOUT FURTHER KNOWLEDGE ABOUT THE CIRCUMSTANCES WE ASSUME, THAT THE SHAVING WAS GENERATED BY SCREWING IN THE SCREW WITH A WRONG ANGLE, SO THAT THE THREAD SCRAPES ON THE EDGE OF THE PLACE (SCREW HOLE). THIS IS THE BASIC CAUSE IN CASES LIKE THAT. A MATERIAL DEFECT OR A MANUFACTURING ERROR CAN BE EXCLUDED. NO CAPA NECESSARY. ASSOCIATED MEDWATCH: 9610612-2019-00259.

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER, REGISTRATION NO. 9610612). EXEMPTION NUMBER: E2014018. HEIGHT: 170CM. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED METAL SHAVINGS DETACHING FROM THE SCREW INTRAOPERATIVELY. THE REPORTER INDICATED THAT FINE METAL SHAVINGS SHEARED OFF AT THE TWO SCREWS. THIS HAPPENED WHEN THE SCREW WAS BEING INSERTED THROUGH THE PLATE HOLE. THIS OCCURRED DESPITE CENTRAL PRE-GRAINING OF THE SCREW HOLES. THE SURGERY TIME WAS EXTENDED GREATER THAN 15 MINUTES, HOWEVER THE OPERATION WAS COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER, NOT YET RECEIVED. ASSOCIATED MEDWATCH: 9610612-2019-00259.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317055 QUINTEX SEMICONSTRAINED SCREW 4.0X14MM IMPLANTS CERVICAL STABILISATIO KWQ AESCULAP AG SC502T 52118739

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention