BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD Ø5.5 HARD L200 TAN

    MDR report key: 3091608 · Received May 3, 2013

    Report

    Report Number
    8030965-2013-02100
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    April 4, 2013
    Manufacturer
    SYNTHES GMBH
    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. 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

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE COMPLAINED ARTICLE WAS SEND TO OUR PRODUCT DEVELOPMENT CENTER FOR FURTHER INVESTIGATION. ACCORDING TO THEIR STATEMENT THE ARTICLE WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. THE IMPLANT WAS FULLY DISASSEMBLED. IT WAS ESTABLISHED, THAT THE CLAMPING RING IS BENT WHICH BLOCKS THE TELESCOPING FEATURE. BECAUSE OF THE DIRECTION OF THE BENDING OF THE CLAMPING RING IT CAN BE INDICATES THAT THE LOCKING SCREW WAS BENT WHILE THE PROCEDURE OF DISSOLVING. THIS DEVELOPMENT LEAD TO EXCESSIVE TIGHTENING OF THE LOCKING SCREW. THE REVIEWS OF THE MANUFACTURING AND MATERIAL DOCUMENTS SHOW NO DEVIATION ACCORDING TO THE SPECIFICATIONS. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: A PATIENT WAS IMPLANTED WITH PERFORATED MATRIX SCREWS DURING A SURGERY ON (B)(6) 2013. ON AN UNKNOWN DATE, IT WAS DISCOVERED THAT THE SCREWS WERE IN A FAULTY POSITION. A REVISION SURGERY WAS CONDUCTED. DURING THE REVISION SURGERY ON (B)(6) 2013, A LOCKING CAP COULD NOT BE SOLVED. THE SURGEON USED A BOLT CUTTER. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 5 OF 6 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193888 ROD Ø5.5 HARD L200 TAN NKB SYNTHES GMBH 7599718

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention