BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANT HOLDER 10 MM

    MDR report key: 3762086 · Received April 21, 2014

    Report

    Report Number
    3000270450-2014-10013
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    March 22, 2014
    Report Date
    March 25, 2014
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HYA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE INITIAL COMPLAINT WAS REVIEWED AND FOUND NOT REPORTABLE. THIS DEVICE IS NOT SIMILAR TO ANY DEVICE SOLD/AVAILABLE IN THE US. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. REVIEW OF THE DEVICE`S TEST PROTOCOL SHOWED THAT THERE WERE NONCONFORMANCIES: IN 3 OF 20 IMPLANT HOLDERS, THE LOCKING SCREW COULD ONLY BE INSERTED IN THE IMPLANT HOLDER WITH LIGHT EXERTION OF FORCE. ALSO THERE WERE SOME VISUAL DEVIATIONS LIKE SLIGHTLY FADED MARKINGS FOUND. HOWEVER, ALL PARTS WERE RELEASED AFTER REWORK. NEXT TO THAT NEITHER THE NEEDED SLIGHT FORCE OF LOCKING SCREW INSERTION NOR THE VISUAL DEVIATIONS WOULD BE COMPLAINT RELATED AS THE COMPLAINT IS REGARDING MOVING OF THE IMPLANT WINGS AND REGARDING ATTACHING THE IMPLANT OR THE LOCKING SCREW. 4 OF 20 IMPLANT HOLDERS HAD SUPERFICIAL DAMAGE. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN OPERATION TO IMPLANT IN-SPACE IMPLANTS, TWO SCREWDRIVERS, AN IMPLANT HOLDER AND TWO TORQUE LIMITERS DID NOT FUNCTION PROPERLY. NO PATIENT ADVERSE CONSEQUENCES HAVE BEEN REPORTED. THE PROCEDURE WAS PROLONGED FOR ABOUT TWENTY-FIVE MINUTES. THIS IS REPORT 3 OF 5 FOR (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239240 IMPLANT HOLDER 10 MM HOLDER HYA SYNTHES SELZACH 8083227

    Patients

    Seq Age Sex Outcome Treatment
    1