BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCK-CAP ONE-STEP F/MATRIX 5.5 TAN

    MDR report key: 3251325 · Received July 29, 2013

    Report

    Report Number
    2520274-2013-04665
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    July 2, 2013
    Report Date
    July 8, 2013
    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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE 510K#: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: SCREWS CAME LOOSE. THE PATIENT HAD AN OPERATION AT ANOTHER HOSPITAL ON (B)(6) 2012. IN THE X-RAY EXAMINATION FOR POSTOPERATIVE COURSE, THE SURGEON FOUND THAT THE RIGHT SIDE ROD SLID OUT FROM T10 SCREW HEAD POSITION TO THE DISTAL DIRECTION ABOUT 2.5CM. THE SURGEON WHO ALSO USED THE MATRIX FOR THE SURGERY WANTED TO KNOW THE CAUSE OF THE MATTER. IT HAS NOT BEEN POSSIBLE TO CONFIRM THE LOOSENING, BUT TO DATE, TWO OF THE RIGHT SIDE SCREW CAME LOOSE AND CANNOT COMPLETELY HOLD ON THE ROD. THEREFORE, IT REQUIRES A FOLLOW-UP SURGERY TO EXCHANGE THE TWO SCREWS FOR NEW ONES AND TIGHTEN UP ONCE AGAIN. THE ARTICLES WILL REMAIN IN THE PATIENT UNTIL THE REMOVAL OPERATION. IT WAS REPORTED THAT THE PATIENT IS DOING WELL. IT WAS REPORTED THAT SURGEON WILL REMOVE THE IMPLANTS IF THE PATIENT CHOOSES TO DO SO. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352779 LOCK-CAP ONE-STEP F/MATRIX 5.5 TAN NKB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention