BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI RIB HOOK CAP/STANDARD

    MDR report key: 2983501 · Received February 28, 2013

    Report

    Report Number
    2530088-2013-00231
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 31, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MDI
    PMA / PMN Number
    H03009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. 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.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. DATE OF EVENT - (B)(6) 2013 PROVIDED BY QUESTIONNAIRE ON 2/15/2013. DATE ILLEGIBLE AND CONFIRMED BY TELEPHONE ON (B)(6) 2013.

    Description of Event or Problem · 1

    A VEPTR REPLACEMENT OF A RIB HOOK DUE TO MIGRATION: PATIENT WAS IMPLANTED WITH VEPTR ON AN UNKNOWN DATE. ON A FOLLOW UP VISIT TO SURGEON AN X-RAY REVEALED THE MIGRATION. THE SALES CONSULTANT DOES NOT KNOW IF THE PATIENT WAS HAVING PAIN AS HE IS A (B)(6) MALE WITH SPINA BIFIDA AND NON VERBAL. WHEN THE SURGEON WAS ATTEMPTING TO MOVE THE HOOK TO ANOTHER RIB WITH THE FORCEPS, THE FORCEPS BROKE IN HALF. THE PIECES WERE RETRIEVED AND THE SURGEON USED THE SECOND INSTRUMENT IN THE SET WITHOUT DELAY TO THE CASE. IT WAS NOTED BY THE CONSULTANT: IT DID NOT APPEAR AS IF THE SURGEON WAS PUTTING THAT MUCH FORCE ON THE INSTRUMENT. NO ADVERSE EFFECT TO THE PATIENT WAS NOTED. THE HOOK WAS MOVED FROM THE 3RD TO THE 4TH RIB. THIS IS 4 OF 4 REPORTS FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS IS 4 OF 4 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86453 TI RIB HOOK CAP/STANDARD RIB HOOK CAP MDI SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention