BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIATRICS 3.5MM LOCKING CORTICAL SCREW, T15 HEX, SIZE 12MM

    MDR report key: 7691678 · Received July 16, 2018

    Report

    Report Number
    3006460162-2018-00054
    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
    0084113211042
    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: H4 UPDATED WITH MANUFACTURING DATE 23 SEP 2016. H6 UPDATED METHOD 4109 AND 3331. H6 UPDATED RESULTS 213. H6 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 DISASSOCIATION.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT DEVICES - ITEM: 00-0907-1203, LOCKING PROXIMAL FEMUR 90 DEGREE X 3.5 MM VARUS PLATE, 12 MM OFFSET, LOT: 052579-E. ITEM: 00-0903-2642, 3.5 MM LOCKING CORTICAL SCREW, T15 HEX, SIZE 42 MM, LOT: 141056-J. ITEM: 00-0903-2642, 3.5 MM LOCKING CORTICAL SCREW, T15 HEX, SIZE 42 MM, LOT: 141056-J. ITEM: 00-0903-2642, 3.5 MM LOCKING CORTICAL SCREW, T15 HEX, SIZE 42 MM, LOT: 009U7. ITEM: 00-0903-2612, 3.5 MM LOCKING CORTICAL SCREW, T15 HEX, SIZE 12 MM, LOT: 163180-J. ITEM: 00-0903-2512, 3.5 MM LOCKING CORTICAL SCREW, T15 HEX, SIZE 12 MM, 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: 3006460162-2018-00049, 3006460162-2018-00050, 3006460162-2018-00051, 3006460162-2018-00052, AND 3006460162-2018-00053.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT FOLLOWING A TRANSVERSE OSTEOTOMY PROCEDURE, 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
    532089 ORTHOPEDIATRICS 3.5MM LOCKING CORTICAL SCREW, T15 HEX, SIZE 12MM LOCKING CORTICAL SCREW HWC ORTHOPEDIATRICS, INC N/A 163647-J 0084113211042

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention SEE H10.