BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVERSHAFT T25 F/URS

    MDR report key: 3123619 · Received May 22, 2013

    Report

    Report Number
    8030965-2013-02354
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 22, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    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. A REQUEST FOR THE DEVICE HISTORY REVIEW FOR THIS LOT HAS BEEN MADE. 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

    AN EVALUATION WAS CONDUCTED AND THE REPORT INDICATES THAT THE FRACTURE SURFACE IS HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY AS WELL. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS RELATED TO A MECHANICAL OVERLOADING DURING USE. DHR REVIEW CONFIRMS THAT THE DEVICE WAS CONFORMING TO SPECIFICATIONS; NO MANUFACTURING RELATED FAULT COULD BE DETECTED. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2013 FOR SCOLIOSIS CORRECTION AND DECOMPRESSION OF THE SPINAL CANAL. WHILE ADJUSTING THE SYSTEM, THE DOCTOR DECDIDED TO GIVE MORE COMPRESSION AT LEVELS L3 AND L4 OF THE RIGHT SIDE. HE DECIDED TO DROP THE CLOSING BUSHING. THE ROD WAS ADJUSTED POLYAXIALLY. WHILE TRYING TO LOOSEN, FORCE WAS APPLIED AND THE TIP OF THE SCREWDRIVER FRACTURED. IT WAS SWAPPED FOR ANOTHER DEVICE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THIS IS 1 OF 1 DEVICE FOR THIS EVENT REPORTED ON COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225672 SCRDRIVERSHAFT T25 F/URS HXX SYNTHES GMBH 7665226

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR