BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URS Ø6 L40

    MDR report key: 3201210 · Received July 2, 2013

    Report

    Report Number
    8030965-2013-04202
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 4, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    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. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO A DEVICE MARKETED IN THE USA. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED.

    Additional Manufacturer Narrative · 1

    THE COMPLAINED ARTICLE WAS SEND TO THE PRODUCT DEVELOPMENT CENTER FOR FURTHER INVESTIGATION. THE COMPLAINED CONDITION IS NORMAL BEHAVIOR OF THE IMPLANT. IN CASES WHEN THE POLYAXIAL SCREW DOES NOT MOVE, WE REQUEST TO USE THE INSTRUMENT 03.636.013 (REMOBILIZER INSTRUMENT) WITH WHICH IT IS POSSIBLE TO BRING THE SCREW BACK IN THE RIGHT POSITION. THE REVIEW ACCORDING THE MATERIAL AND MANUFACTURING DOCUMENTS SHOW NO DEVIATION REGARDING TO OUR SPECIFICATIONS. NO PRODUCT FAULT COULD BE DETECTED. THIS COMPLAINT IS INDETERMINATE. PLACEHOLDER.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: SCREW HEAD IS STICKING DURING A PROCEDURE ON AN UNKNOWN DATE. AFTER FIXATION WITH LOCKING CAP, ANGULAR STABLE ADJUSTMENT OF PEDICLE SCREW. FURTHERMORE FIXATION WITH THE OUTER AND INNER BLUE FIXATION SCREW. A RENEWED ALIGNMENT OF THE ROD WAS NOT POSSIBLE. THIS IS REPORT 1 OF 1 FOR (B)(4)..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303286 URS Ø6 L40 HWC SYNTHES GMBH 8073237

    Patients

    Seq Age Sex Outcome Treatment
    1