BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISTRACTION

    MDR report key: 10829430 · Received November 12, 2020

    Report

    Report Number
    9610905-2020-00125
    Event Type
    Injury
    Date Received
    November 12, 2020
    Date of Event
    October 30, 2020
    Report Date
    October 31, 2020
    Manufacturer
    KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
    Product Code
    PBJ
    UDI-DI
    00888118114310
    PMA / PMN Number
    K163315
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS PERFORMED USING A STEREO MICROSCOPE REVEALED TENSILE CRACKS. FURTHER OBSERVATION DETERMINED THERE WERE NO INDICATIONS OF MATERIAL OR MANUFACTURING DEFECTS. THE COMPLAINT PERCENTAGE WAS CALCULATED, AND IT IS DETERMINED THAT THE COMPLAINT PERCENTAGE FALLS WITHIN THE DESIGN RISK LIMITS ADHERED TO AT KLM. DURING THE INVESTIGATION THE PRODUCT LOT NUMBER IDENTIFIED WAS REVIEWED IN THE DEVICE HISTORY RECORDS. THE DHR REVIEW SHOWED NO DISCREPANCIES OR ANOMALIES. THE INVESTIGATION RESULTS CONCLUDE THAT THE ROOT CAUSE FOR BREAKAGES WERE DUE TO STRUCTURAL FAILURE OF THE DEVICE DUE TO MECHANICAL OVERLOAD. IF FURTHER INFORMATION IS OBTAINED THAT MIGHT ADD VALUE TO THE CONTENTS OF THE INVESTIGATION REPORT, AN ADDITIONAL FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). REFERENCE EXEMPTION NUMBER E2017029. MULTIPLE MDR REPORTS WERE FILED FOR THIS PATIENT, PLEASE SEE ASSOCIATED REPORT: MDR: 9610905-2020-00124.

    Description of Event or Problem · 1

    IT WAS REPORTED A DISTRACTOR BROKE. IT WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1294373 DISTRACTION DISTRACTION PBJ KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG 51-405-42-71 33363551 00888118114310

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Other