BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL

    MDR report key: 7200467 · Received January 17, 2018

    Report

    Report Number
    8030965-2018-50427
    Event Type
    Malfunction
    Date Received
    January 17, 2018
    Date of Event
    December 22, 2017
    Report Date
    December 22, 2017
    Manufacturer
    OBERDORF : SYNTHES PRODUKTIONS GMBH
    Product Code
    KTT
    PMA / PMN Number
    K122455
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS UNKNOWN. IT IS UNKNOWN WHEN THE EVENT OCCURRED. THIS REPORT IS FOR A CLAMP - UNKNOWN LOT. ADDITIONAL PROCODE LXT. THIS DEVICE IS USED IN EXTERNAL FIXATION AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART HAS NOT BEEN RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    IT WAS REPORTED THAT THE CLAMP WAS UNABLE TO HOLD. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR A CLAMP. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46005 LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL APPLIANCE, FIXATION, NAIL KTT OBERDORF : SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1