BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHN MULTILOC Ø8 IZQ CAN L160 TAN

    MDR report key: 8341265 · Received February 14, 2019

    Report

    Report Number
    8030965-2019-61050
    Event Type
    Injury
    Date Received
    February 14, 2019
    Date of Event
    January 25, 2019
    Report Date
    January 24, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    JDS
    UDI-DI
    07611819431034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE 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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE PHN MULTILOC Ø8 IZQ CAN L160 TAN IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. (B)(4). 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 REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE MULTILOC HUMERAL NAIL ON (B)(6) 2019. THE PATIENT HAD A NARROW MEDULLARY CAVITY AND THE NAIL WAS INSERTER WITH HAMMERING. DURING DISTAL LOCKING, A CRACK WAS OBSERVED IN THE BONE AT THE TIP OF THE NAIL. A SLING FIXATION WAS APPLIED TO THE PATIENT AND HE WILL START PENDULUM EXERCISE ABOUT A WEEK AFTER THE SURGERY. THE SURGEON COMMENTED THAT IS UNKNOWN WHETHER THE CRACK OCCURRED AT THE TIME OF INJURY OR DURING THE SURGERY DUE TO IT WAS A HIGH ENERGY TRAUMA. THE SURGERY WAS COMPLETED WITHOUT ADDITIONAL TREATMENT. PATIENT'S OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131828 PHN MULTILOC Ø8 IZQ CAN L160 TAN NAIL, FIXATION, BONE JDS OBERDORF SYNTHES PRODUKTIONS GMBH 07611819431034

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention