BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    USS LOWPROFILE PEDICSCREW Ø7 SIDE-OPEN L

    MDR report key: 3093577 · Received May 6, 2013

    Report

    Report Number
    8030965-2013-02105
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Report Date
    April 23, 2009
    Manufacturer
    SYNTHES GMBH
    Product Code
    MCV
    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 DEVICE MARKETED IN THE USA. AN ADDITIONAL EVALUATION WAS CONDUCTED BY SYNTHES (B)(4) AND THE REPORT INDICATES: THE INVESTIGATION SHOWED THE ETCHING DID NOT CONFORM TO SPECIFICATIONS. IT WAS CONFIRMED THE DIAMETER OF THE PEDICLE SCREW WAS ETCHED AS 4.2MM, INSTEAD OF 7MM AND IT WAS DETERMINED THE SCREW WAS MANUFACTURED FROM A LOT DATING BACK TO JULY 2008. FURTHER, ALTHOUGH OTHER DEVICES FROM THE SAME LOT WHERE ALSO RELEASED DURING THE FINAL INSPECTION, THERE HAVE NOT BEEN ANY REPORTS OF ANY EVENTS INVOLVING THESE DEVICES. ALSO, A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE SCREWS WERE WRONGLY ETCHED. THE SCREWS WERE MARKED AS 4.2MM, WHEN IN ACTUALITY THEY ARE 7 MILLIMETERS. THIS REPORT IS FOR A USS LOW PROFILE PEDICLE SCREW, 7MM SIDE-OPEN. THIS IS 1 OF 1 DEVICES FOR THIS EVENT REPORTED ON COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196995 USS LOWPROFILE PEDICSCREW Ø7 SIDE-OPEN L MCV SYNTHES GMBH 2390589

    Patients

    Seq Age Sex Outcome Treatment
    1