BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5MM TI MATRIX SCREW 35MM THREAD LENGTH

    MDR report key: 3931141 · Received July 14, 2014

    Report

    Report Number
    2520274-2014-12518
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Report Date
    June 16, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    NKB
    PMA / PMN Number
    PK100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2014 THE PATIENT HAD A DEVICE IMPLANTED FOR LUMBAR DISC HERNIATION (L4-5). X-RAY ON AN UNKNOWN DATE REVEALED THE POLYAXIAL HEAD OF THE MATRIX-POP-ON SCREW HAD COME OFF. THE SURGEON WILL NOT BE PERFORMING ADDITIONAL SURGERY AS THE FACET REMAINED IN PLACE. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410655 5.5MM TI MATRIX SCREW 35MM THREAD LENGTH ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1