BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 26MM

    MDR report key: 8014050 · Received October 29, 2018

    Report

    Report Number
    8030965-2018-57697
    Event Type
    Malfunction
    Date Received
    October 29, 2018
    Date of Event
    October 10, 2018
    Report Date
    October 10, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    UDI-DI
    07611819444195
    PMA / PMN Number
    K100776
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE PRO CODE: HRS. POSSIBLE LOT NUMBERS: L221250 OR 9134142. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. ADDITIONALLY, DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT INITIALLY, ON (B)(6) 2017, A VARIABLE ANGLE FOREFOOT/MIDFOOT WAS APPLIED FOR HALLUX VALGUS AND ARTHROPATHY OF THE LISFRANC JOINT. FOUR (4) 2.7MM TITANIUM VARIABLE ANGLE LOCKING COMPRESSION WAS USED INTO THE VARIABLE ANGLE LOCKING COMPRESSION T-FUSION. ON (B)(6) 2018, AN EXPLANTATION SURGERY WAS PERFORMED. DURING THE REMOVAL SURGERY, WHILE TRYING TO REMOVE THE VARIABLE ANGLE LOCKING COMPRESSION SCREWS, THREE (3) OUT OF FOUR (4) SCREWS BROKE JUST UNDER THE SCREW HEADS. THERE IS A POSSIBILITY THAT BROKEN PIECES REMAINED INSIDE THE PATIENT¿S BODY. THE PATIENT OUTCOME AND ANY SURGICAL DELAY WERE UNKNOWN. CONCOMITANT DEVICE: VA T-FUSION (PART: 04.211.253S, LOT: H307464, QUANTITY: 1). THIS REPORT IS FOR ONE (1) LOCKING SCREW. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855599 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 26MM SCREW,FIXATION,BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH 07611819444195

    Patients

    Seq Age Sex Outcome Treatment
    1