BEUDAMED
    FDA Adverse Event Other Summary report: N

    LACTOSORB PECTUS STABILIZER

    MDR report key: 1172624 · Received September 10, 2008

    Report

    Report Number
    1032347-2008-00057
    Event Type
    Other
    Date Received
    September 10, 2008
    Date of Event
    August 7, 2008
    Report Date
    August 15, 2008
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    K071577
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DOCTOR INDICATED SHE IS NOT SURE IF FRACTURE CAUSED BAR DISPLACEMENT OR IF HAPPENED AS A RESULT OF THE BAR DISPLACEMENT. CURRENT INFO IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFO 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

    PECTUS BAR & LACTOSORB PECTUS STABILIZER IMPLANTED IN 2008. PATIENT PRESENTED IN AUGUST WITH BAR DISPLACEMENT, REVISION SURGERY PERFORMED APPROX TWO MONTHS LATER. AT THE TIME OF THE REVISION SURGERY, FOUND STABILIZER HAD FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LACTOSORB PECTUS STABILIZER RESORBABLE STABILIZER HRS BIOMET MICROFIXATION 740230

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization