BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.5MM TI HARD ROD 200MM

    MDR report key: 3922351 · Received July 9, 2014

    Report

    Report Number
    2520274-2014-12447
    Event Type
    Injury
    Date Received
    July 9, 2014
    Report Date
    June 10, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    NKB
    PMA / PMN Number
    PK100952
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DATE OF EVENT IS UNKNOWN. ADDITIONAL CODES- MNH, MNI, KWQ, KWP. IMPLANT/EXPLANT DATE IS UNKNOWN. 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. 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

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO ADJACENT LEVEL COMPLICATIONS. THE INITIAL LUMBAR FUSION SURGERY WAS A LEVEL L4-S1 AND SCREWS, LOCKING CAPS AND RODS WERE IMPLANTED FROM LEVEL L4 TO S1 ON AN UNKNOWN DATE. DURING THE REVISION EXTENSION OF THE MATRIX HARDWARE PROCEDURE, FOR A LUMBAR FUSION AT LEVEL L3 AND ILIUM; THE SCREWDRIVER SLEEVES WERE NOT ENGAGING THE SCREWS WHEN THE SCRUB TECH WAS TRYING TO INSERT. THE SCRUB TECH CHANGED TO A SHORTER SCREWDRIVER BIT AND WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCESS. AFTER THE PROCEDURE, IT WAS NOTICED THAT THE TIP OF THE SLEEVES WERE BROKEN OFF PREVENTING IT FROM ENGAGING THE SCREW. IT WAS REPORTED THERE WAS A 10 MINUTE DELAY IN PROCEDURE AND THE PATIENT STATUS WAS FINE. THIS IS REPORT 8 OF 9 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399525 5.5MM TI HARD ROD 200MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention