BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKSCR Ø5 SELF-TAP L70 TAN

    MDR report key: 3080622 · Received April 26, 2013

    Report

    Report Number
    8030965-2013-02023
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    February 19, 2013
    Report Date
    March 28, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    K962011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION EVALUATION WAS CONDUCTED AND THE REPORT INDICATES THAT THE DEVICE LOCKED INTO THE PLATE THREAD. THE DEVICE COULD NOT BE REMOVED VIA NORMAL EXTRACTION. THE INSERTION ANGLE OF THE SCREW WAS VISUAL CHECKED AND FOUND TO BE OKAY. WE ASSUMED THAT THE CAUSE OF THIS PROBLEM OCCURRED THROUGH COLD WELDING OF THE SCREW HEAD TREAD TO THE THREAD OF THE PLATE. NO ABNORMAL FINDINGS WERE IDENTIFIED AND THE DEVICE WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. NO PRODUCT FAULT COULD BE DETECTED. IMPLANT DATE ¿(B)(6) 2012. PLACEHOLDER.

    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. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: A PROCEDURE ON (B)(6) 2013 WAS PERFORMED ON PATIENT, DUE TO THE PATIENT ACQUIRING AN INFECTION AND HAVING A FALSE JOINT. INITIALLY THE SURGEON HAD PLANNED TO ADD AN ADDITIONAL LOCKING COMPRESSION PLATE (LCP), BUT OPTED TO REMOVE THE PLATE DUE TO INFECTION. DURING THE REMOVAL PROCEDURE THE SURGEON REALIZED ONE OF THE LOCKING SCREWS WOULD NOT TURN AT ALL, SO THE SURGEON TURNED THE PLATE AND REMOVED THE SCREW. IT WAS REPORTED THE SURGEON BELIEVED THE CAUSE OF THIS WAS DUE TO THE INSERTION ANGLE BEING INCORRECT (CONTACT AREA BETWEEN THE PLATE AND SCREW REDUCING), AND THAT IT HAD BEEN COLD WELDED. IT WAS ALSO REPORTED THE LCP PLATE AND SCREW WERE IMPLANTED ON (B)(6) 2012. THIS REPORT IS FOR A 5.0MM TITANIUM LOCKING HEAD SCREW, SELF-TAPPING 70MM LENGTH. THIS IS 1 OF 2 DEVICES FOR THIS EVENT REPORTED ON (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182337 LOCKSCR Ø5 SELF-TAP L70 TAN HWC SYNTHES GMBH 7855590

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention