BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L5

    MDR report key: 2993819 · Received March 8, 2013

    Report

    Report Number
    2520274-2013-01341
    Event Type
    Injury
    Date Received
    March 8, 2013
    Date of Event
    January 17, 2013
    Report Date
    February 6, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    JEY
    PMA / PMN Number
    K022012
    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. ADDITIONAL NARRATIVE: THE SCREW SHAFT REMAINS IMPLANTED. THE SCREW HEAD WAS RETRIEVED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. BASED ON THE PERFORMED INVESTIGATION NO MATERIAL FAULT COULD BE DETECTED. THE SCREW FAILED BY A HIGH USE OF FORCE DURING SCREWING. A COMBINATION OF FRICTION WITH THE PLATE AND AN UNFAVORABLE ANGLE BETWEEN THE SCREW AND THE BONE DURING SCREWING MAY HAVE RESULT IN A HIGH RESISTANCE AND THIS CAN LEAD TO THE BREAKAGE OF THE SCREW. THE ORIENTED FRACTURES ARE A CLEAR INDICATION OF A DUCTILE VIOLENT RUPTURE CAUSED BY A TORSIONAL OVERLOAD. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A FIXATION OF BONY FRAGMENTS OF THE SKULL PROCEDURE, THREE SCREWS WERE TWISTED OFF DURING INSERTION. IT WAS REPORTED THE SCREWS BROKE IN THE MIDDLE SECTOR OF THE SCREW SHAFT. THE SCREW HEAD WAS RETRIEVED AND RETURNED FOR EVALUATION. THE SCREW SHAFT REMAINS IMPLANTED. THIS IS 3 OF 3 REPORTS FOR THE SAME EVENT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98829 CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L5 JEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention