BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCK-CAP ONE-STEP F/MATRIX 5.5 TAN

    MDR report key: 2944451 · Received February 5, 2013

    Report

    Report Number
    2530088-2013-00102
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    June 29, 2012
    Report Date
    July 5, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    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. DEVICE WAS RETURNED TO MANUFACTURER (B)(4) 2012. INVESTIGATION COORDINATED BY SYNTHES (B)(4). REPORT RECEIVED INDICATES THE MEASURABLE DIMENSIONS OF THE PLATE WERE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. EXAMINATION OF THE RAW MATERIAL TESTING CERTIFICATES AND THE MANUFACTURING RECORDS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH AO/ASIF SPECIFICATION AND WITH THE INTERNATIONAL STANDARD. THE FRACTURE IS HOMOGENOUS WHICH INDICATES MATERIAL CONFORMITY. NO PRODUCT FAULT COULD BE DETECTED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED. NO ISSUES WERE FOUND.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(4) INDICATES A HOSPITAL IN (B)(6) REPORTED: PATIENT WAS IMPLANTED MEDICAL DEVICE ON AN UNKNOWN DATE, AND IT WAS DISCOVERED FOURTEEN DAYS LATER TO HAVE THE HEAD OF THE PEDICLE SCREW LOOSE FROM THE SCREW AT S1 LEFT. DISCOVERY MADE WHEN X-RAY WAS TAKEN ON (B)(6) 2012. MEDICAL/SURGICAL INTERVENTION WAS NEEDED. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48596 LOCK-CAP ONE-STEP F/MATRIX 5.5 TAN LOCKING CAP NKB SYNTHES BRANDYWINE 6923814

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention