BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIATRICS 3.5MM LOCKING CORTICAL SCREW, T15 HEX, SIZE 42MM

    MDR report key: 7691654 · Received July 16, 2018

    Report

    Report Number
    3006460162-2018-00049
    Event Type
    Injury
    Date Received
    July 16, 2018
    Date of Event
    June 15, 2018
    Report Date
    November 21, 2019
    Manufacturer
    ORTHOPEDIATRICS, INC
    Product Code
    HWC
    UDI-DI
    0084113211097
    PMA / PMN Number
    K100240
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: UPDATED WITH MANUFACTURING DATE 11 JUN 2014. UPDATED METHOD 4109 AND 3331. UPDATED RESULTS 213. UPDATED CONCLUSION 61. PARTS NOT RETURNED FOR EVALUATION. THE DHR WAS INSPECTED AND ALL DIMENSIONS WERE WITHIN THE ACCEPTABLE TOLERANCES. THE ROOT CAUSE IS UNKNOWN. FAILURE TO ADEQUATELY TIGHTEN THE SET SCREWS CAN RESULT IN DISSASSOCIATION.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS - ITEM: 00-0907-1203, LOCKING PROXIMAL FEMUR 90 DEGREE X 3.5MM VARUS PLATE, 12MM OFFSET, LOT: 052579-E; ITEM: 00-0903-2642, 3.5MM LOCKING CORTICAL SCREW, T15 HEX, SIZE 42MM, LOT: 141056-J; ITEM: 00-0903-2642, 3.5MM LOCKING CORTICAL SCREW, T15 HEX, SIZE 42MM, LOT: 009U7; ITEM: 00-0903-2612, 3.5MM LOCKING CORTICAL SCREW, T15 HEX, SIZE 12MM, LOT: 163180-J; ITEM: 00-0903-2512, 3.5MM LOCKING CORTICAL SCREW, T15 HEX, SIZE 12MM, LOT: 163647-J; ITEM: 00-0903-2512, 3.5MM LOCKING CORTICAL SCREW, T15 HEX, SIZE 12MM, LOT: 163647-J. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ORTHOPEDIATRICS FOR INVESTIGATION AS IT WAS RETAINED BY THE PATIENT'S FAMILY. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3006460162-2018-00050, 3006460162-2018-00051, 3006460162-2018-00052, 3006460162-2018-00053, AND 3006460162-2018-00054.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT FOLLOWING A TRANSVERSE OSTEOTOMY, THE IMPLANTED SCREWS WERE DISCOVERED TO BE BACKING OUT OF THE PLATE. THE PATIENT UNDERWENT A REVISION PROCEDURE TO REPLACE THE PLATE AND SCREWS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531450 ORTHOPEDIATRICS 3.5MM LOCKING CORTICAL SCREW, T15 HEX, SIZE 42MM LOCKING CORTICAL SCREW HWC ORTHOPEDIATRICS, INC N/A 141056-J 0084113211097

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention