BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.0MM TI MATRIX POLYAXIAL SCREW 40MM THREAD LENGTH

    MDR report key: 3182669 · Received June 21, 2013

    Report

    Report Number
    2520274-2013-03629
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    May 23, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. THIS DEVICE WAS USED FOR TREATMENT.

    Description of Event or Problem · 1

    DURING L2 ¿ S1 SPINAL FUSION SURGERY ON (B)(6) 2013, THE HEAD OF A 6.0MM X 40MM MATRIX SCREW CAME OFF AT L2 WHILE THE SURGEON WAS USING THE SIMPLE PERSUADER DURING FINAL TIGHTENING. THE BROKEN SCREW WAS DISCOVERED VIA X-RAY IN THE OR. AS A RESULT, THE SURGEON REMOVED THE LOCKING CAPS AND ONE ROD AND REPLACED THE BROKEN SCREW WITH A 6.0 X 45MM MATRIX SCREW AND REASSEMBLED THE CONSTRUCT. IT WAS REPORTED THAT SURGERY WAS PROLONGED APPROXIMATELY 5 MINUTES. A FINAL X-RAY TAKEN DURING SURGERY WAS APPROVED BY THE SURGEON. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283982 6.0MM TI MATRIX POLYAXIAL SCREW 40MM THREAD LENGTH NKB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1