BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING PROXIMAL FEMUR SYSTEM CORTICAL SCREWS

    MDR report key: 9713512 · Received February 14, 2020

    Report

    Report Number
    3006460162-2020-00018
    Event Type
    Injury
    Date Received
    February 14, 2020
    Date of Event
    February 21, 2019
    Report Date
    February 10, 2020
    Manufacturer
    ORTHOPEDIATRICS, CORP
    Product Code
    HWC
    PMA / PMN Number
    K162307
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: 130 DEG X 4.5MM PLATE, 3 HOLE, ITEM NUMBER: 00-0907-2203 LOT NUMBER: 052633-G; 4.5MM CANNULATED LOCKING SCREW, 65MM ITEM NUMBER: 00-0907-4765 LOT NUMBER: M93172-E; 4.5MM NON LOCKING CORTICAL SCREW FULL THREAD 28MM, ITEM NUMBER: 00-0907-4528 LOT NUMBER: 172162-F; 4.5MM NON LOCKING CORTICAL SCREW FULL THREAD 28MM, ITEM NUMBER: 00-0907-4528 LOT NUMBER: 170677-F; 4.5MM NON LOCKING CORTICAL SCREW FULL THREAD 28MM, ITEM NUMBER: 00-0907-4528 LOT NUMBER: 172162-F; 4.5MM CANNULATED LOCKING CORTICAL SCREW, 70MM, ITEM NUMBER: 00-0907-4770 LOT NUMBER: M48083. COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION. REPORTED EVENT WAS CONFIRMED THROUGH RADIOGRAPHIC IMAGES PROVIDED BY THE CUSTOMER. DHR WAS REVIEWED. NO DEVIATIONS OR REWORK WAS REPORTED. RISK MANAGEMENT FILE REVIEW WAS DEEMED APPROPRIATE. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE IS UNKNOWN BUT THE PATIENT'S POOR BONE CONDITION AS NOTED BY THE SURGEON COULD BE A CONTRIBUTING FACTOR. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3006460612-2020-00017 REPORTS THE SECOND LOOSE SCREW, 4.5MM CANNULATED LOCKING CORTICAL SCREW, 70MM,: ITEM NUMBER; 00-0907-4770, LOT NUMBER; M48083. 3006460162-2020-00030 REPORTS THE BROKEN SCREW LEFT IN THE PATIENT; 4.5MM CANNULATED LOCKING SCREW, 65MM ITEM NUMBER: 00-0907-4765 LOT NUMBER: M93172-E.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A REVISION SURGERY DUE TO ONE BROKEN SCREW AND TWO SCREW BACKING OUT OF THE PLATE. THESE TWO LOOSE SCREWS WERE REPLACED DURING THE REVISION SURGERY WHILE THE REMAINING SCREWS AND PLATE WERE NOT REPLACED. THE FRACTURED SCREW WAS LEFT IN THE PATIENT'S BONE. THE SURGEON NOTED THE POOR BONE QUALITY OF THE PATIENT WHICH CAUSED SOME MICROMOVEMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177651 LOCKING PROXIMAL FEMUR SYSTEM CORTICAL SCREWS 4.5MM CANNULATED LOCKING CORTICAL SCREW, 70MM HWC ORTHOPEDIATRICS, CORP 140107

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention