BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITANIUM PECTUS ELONGATED STAB

    MDR report key: 8583794 · Received May 6, 2019

    Report

    Report Number
    0001032347-2019-00269
    Event Type
    Injury
    Date Received
    May 6, 2019
    Report Date
    July 22, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    UDI-DI
    00841036124120
    PMA / PMN Number
    K061384
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF EVIDENCE SUGGESTING THE REVISION WAS PERFORMED. THE PECTUS BAR AND STABILIZER WERE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT 45 DAYS POST-OPERATION THE PECTUS BAR FLIPPED ANTERIORLY. THE DISTRIBUTOR IS REQUESTING A NEW BAR WITH A BIT MORE BEND IN THE TAILS THUS RESULTING IN A TIGHTER FIT WHICH WOULD BETTER ACCOMMODATE THE PATIENT. NO PHOTOS, SCANS, X-RAYS, OR PHYSICIANS REPORTS WERE PROVIDED. BECAUSE A REVISION SURGERY OCCURRED, THE COMPLAINT IS CONFIRMED. FUNCTIONAL TESTING WAS DONE BY INSERTING THE PECTUS BAR INTO THE STABILIZER AND APPLYING FORCE TO ATTEMPT TO LOOSEN AND FLIP THE BAR. THE BAR COULD NOT BE FORCED THROUGH THE STABILIZER GROOVE AND FLIPPED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2019-00265-1.

    Description of Event or Problem · 0

    DISTRIBUTOR MICHAEL MCKELVEY, REPORTED A REVISION IS PLANNED DUE TO THE "LOWER BAR FLIPPING".

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT IDENTIFIED - FIRST INITIAL: UNKNOWN; SECOND INITIAL: (B)(6). CONCOMITANT MEDICAL PRODUCT - ZIMMER BIOMET TITANIUM PECTUS BAR CATALOG #: PT-2871 LOT #: 885130. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2019-00265.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION IS PLANNED DUE TO THE LOWER BAR FLIPPING. THE BAR WAS NOTED TO BE FLIPPED ANTERIORLY 45 DAYS POST OP DUE TO POOR DESIGN. THE SURGEON WAS AFRAID TO MAKE ANY CHANGES TO THE BAR DURING THE SURGERY, BASED ON OUR INSTRUCTIONS TO AVOID DOING ANYTHING THAT MAY COMPROMISE THE STRENGTH OF THE BAR. THE REVISION IS SCHEDULED FOR (B)(6) 2019. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376789 TITANIUM PECTUS ELONGATED STAB PLATE, FIXATION, BONE HRS BIOMET MICROFIXATION N/A 958930 00841036124120

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R