BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISTRACTION

    MDR report key: 17607193 · Received August 23, 2023

    Report

    Report Number
    9610905-2023-00042
    Event Type
    Injury
    Date Received
    August 23, 2023
    Date of Event
    July 26, 2023
    Report Date
    May 15, 2024
    Manufacturer
    KLS MARTIN SE & CO. KG
    Product Code
    MQN
    UDI-DI
    00888118113405
    PMA / PMN Number
    K010139
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS PERFORMED ON THE BASIS OF COMPLAINT STATISTICS AS NO DEVICE WAS RETURNED FOR EVALUATION. 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 FAILURE ROOT CAUSE CANNOT BE DETERMINED DUE TO NO DEVICE BEING RETURNED. 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: D3 ESTABLISHMENT NAME - KLS MARTIN SE & CO. KG. G1 CONTACT OFFICE ESTABLISHMENT NAME - KLS-MARTIN L.P. G1 CONTACT OFFICE MANUFACTURING SITE NAME AND ADDRESS - KLS MARTIN SE & CO. KG. KOLBINGER STRASSE 10. MUEHLHEIM/DONAU, DEU 78570, DEU.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SCREWS SECURING A DISTRACTOR BECAME LOOSE FROM BONE. THE PHYSICIAN REMOVED THE SCREWS AND REPLACED THEM WITH THE SAME SIZE AND MODEL SCREWS WHILE LEAVING THE DISTRACTOR IN PLACE. THE SCREWS WERE NOTED TO BE INTACT AND UNDAMAGED UPON EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1524790 DISTRACTION DISTRACTOR SCREW MQN KLS MARTIN SE & CO. KG 50-347-07-61 33507577 00888118113405

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Female Other