BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCK-CAP ONE-STEP F/MATRIX 5.5 TAN

    MDR report key: 2842722 · Received November 21, 2012

    Report

    Report Number
    2520274-2012-03319
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    October 19, 2012
    Report Date
    October 26, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. POSSIBLE LOT NUMBERS: 7900101 OR 8000289. EXPIRATION DATES: LOT 7900101: 5/01/2022: LOT 8000289: 7/03/2012. MANUFACTURING DATES. LOT 7900101: 4/17/2012: LOT 8000289: 7/03/2012. ACCORDING TO THE COMPLAINT DESCRIPTION THE LOT NUMBER WAS EITHER LOT 7900101 OR 8000289. THE MANUFACTURING DOCUMENTS FOR BOTH LOTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. NO MATERIAL WAS SENT BACK FOR INVESTIGATION. THEREFORE NO INVESTIGATION IS POSSIBLE AND THE CAUSE OF THIS OCCURRENCE CAN NOT BE DEFINED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(4) PROVIDES INFORMATION FROM A FACILITY IN (B)(6) REGARDING A LOCKING CAP ASSOCIATED WITH AN INTERVERTEBRAL FIXATION, L4 - L5, PROCEDURE. THE SURGEON TRIED TO LOOSEN THE LOCKING CAPS IN ORDER TO PLACE THEM AGAIN UPON OBSERVING THAT THE SCREW ON THE RIGHT SIDE OF THE L4 WAS SLIGHTLY DISPLACED IN A LATERAL DIRECTION. ACCORDING TO THE INSTRUCTION, HE TRIED TO REMOVE THE LOCKING CAP AT L5, TURNING IN A COUNTER DIRECTION MANY TIMES, AND ATTEMPTING TO USE DRIVERS, STRIKING THEM WITH A HAMMER (BREAKING BOTH DRIVERS); HOWEVER, IT NEVER LOOSENED. THE OTHER LOCKING CAP WAS SUCCESSFULLY LOOSENED AT THE L4. REPORTEDLY, THERE WAS NO PROBLEM WHILE PLACING THE LOCKING CAPS INITIALLY, AND IT WAS CONFIRMED THAT THEIR CROSS THREADS AND SCREW HEADS HAD NO IRREGULARITY DURING THE OPERATION. THIS IS REPORT #1 OF 5 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCK-CAP ONE-STEP F/MATRIX 5.5 TAN LOCKING CAP NKB SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 2 DRIVERS