BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCK-CAP ONE-STEP F/MATRIX 5.5 TAN

    MDR report key: 3230685 · Received July 16, 2013

    Report

    Report Number
    2530088-2013-01045
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    April 15, 2013
    Report Date
    June 26, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: REVIEW OF THE DHRS SHOWED THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Additional Manufacturer Narrative · 1

    AN EVALUATION WAS CONDUCTED AND IT STATES THAT THE T25 RECESSES OF THE LOCKING CAPS ARE HEAVILY DAMAGED. A FUNCTIONAL TEST WAS PERFORMED ENGAGING THE LOCKING CAPS BY HAND IN TWO MATRIX SCREW HEADS. NO FAILURE WAS OBSERVED WITH THE ARTICLE OF LOT NUMBER 7254961. THE DEVICE PASSED THE REQUIRED FUNCTIONAL TEST SUCCESSFULLY. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: TWO LOCKING CAPS COULD NOT BE LOCKED DURING SURGERY. THE SURGEON REMOVED IT AND CHANGED TO REPLACEMENT UNITS. ONE LOCKING CAP COULD NOT BE REMOVED AND WAS LEFT IN PLACE. THE SCREW AND RODS WERE NO PROBLEM. THE SURGERY WAS DELAYED. THE EVENT DID NOT REQUIRE ADDITIONAL MEDICAL TREATMENT. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329070 LOCK-CAP ONE-STEP F/MATRIX 5.5 TAN NKB SYNTHES BRANDYWINE 7254961

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR