BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISTRACTION

    MDR report key: 19447552 · Received June 3, 2024

    Report

    Report Number
    9610905-2024-00030
    Event Type
    Injury
    Date Received
    June 3, 2024
    Date of Event
    May 7, 2024
    Report Date
    July 9, 2024
    Manufacturer
    KLS MARTIN SE & CO. KG
    Product Code
    PBJ
    UDI-DI
    00888118114471
    PMA / PMN Number
    K163315
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS PERFORMED IN THE LAB AND 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 KLS SE. 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 IS ORGANIC MATTER PRESENT IN THE MECHANISM AS NO DEVICE ISSUE WAS FOUND. IF FURTHER INFORMATION IS OBTAINED THAT MIGHT ADD VALUE TO THE CONTENTS OF THE INVESTIGATION REPORT, AN ADDITIONAL FOLLOW-UP REPORT WILL BE SUBMITTED. CORRECTIONS: G1- UPDATED COMPANY NAME ADDRESS.

    Additional Manufacturer Narrative · 0

    LOT NUMBERS: 33484300; 33500960.

    Description of Event or Problem · 0

    IT WAS REPORTED THE DISTRACTOR WAS NOT ADVANCING AS EXPECTED. IT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629629 DISTRACTION DISTRACTOR PBJ KLS MARTIN SE & CO. KG 51-563-30-71 SEE H11 00888118114471

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other