BEUDAMED
    FDA Adverse Event Injury Summary report: N

    01-3801

    MDR report key: 2070294 · Received April 27, 2011

    Report

    Report Number
    1032347-2011-00057
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 19, 2011
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    K981789
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS EXPLANTED. THE TECHNIQUE BROCHURE INDICATES TO USE NON-ABSORBABLE SUTURES. "SECURE THE STABILIZER TO THE BAR WITH A "FIGURE-8 SUTURE" AROUND THE JUNCTION OF BOTH DEVICES WITH NO. 3 CARDIAC WIRE OR SIZE "O" NON-ABSORBABLE SUTURE. SECURE THE HOLES IN THE BAR AND STABILIZER TO THE CHEST WALL MUSCLES WITH SIZE "O" ABSORBABLE OR NON-ABSORBABLE SUTURE ATTACHED TO A UR 6 (RIGHT-ANGLE) NEEDLE." ABSORBABLE SUTURES WERE USED IN THE INITIAL SURGERY. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A PECTUS BAR AND 2 STABILIZERS IMPLANTED IN (B)(6) 2009. THE STABILIZERS WERE FIXATED WITH RESORBABLE SUTURE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2011 TO REFIXATE THE STABILIZERS AS THEY HAD SHIFTED. THEY WERE REFIXATED WITH NON RESORBABLE SUTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 01-3801 ELONGATED PECTUS STABILIZER HRS BIOMET MICROFIXATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization