BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.0MM TI MATRIX SCREW 50MM THREAD LENGTH

    MDR report key: 3020297 · Received March 25, 2013

    Report

    Report Number
    2530088-2013-00408
    Event Type
    Malfunction
    Date Received
    March 25, 2013
    Report Date
    February 8, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. THIS REPORT IS PART OF THE SERVICE AND REPAIR DOCUMENTATION REMEDIATION. DEVICES THAT WERE RECEIVED BY SERVICE AND REPAIR HAVE EITHER BEEN REPAIRED AND RETURNED TO THE CUSTOMER OR DISCARDED BY SYNTHES, MAKING FURTHER PRODUCT EVALUATION BY MANUFACTURING OR ENGINEERING IMPOSSIBLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL INFORMATION STATING NO ADVERSE EFFECT ON THE PATIENT.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    SERVICE AND REPAIR REPORT STATES THAT DURING AN L4-S1 TLIF SURGERY THERE WAS A METAL SHAVING FROM A REMOVED SCREW THAT STUCK THE SCRUB TECH DURING THE SYNTHES SPINE MATRIX SCREW SYSTEM PROCEDURE. NO ADDITIONAL INFORMATION AVAILABLE.

    Description of Event or Problem · 1

    THIS EVENT OCCURED DURING SURGERY, WITH NO ADVERSE EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121678 6.0MM TI MATRIX SCREW 50MM THREAD LENGTH ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR