BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIATRICS 3.5MM LOCKING CORTICAL SCREW, T15 HEX, 50MM

    MDR report key: 7651936 · Received June 29, 2018

    Report

    Report Number
    3006460162-2018-00045
    Event Type
    Injury
    Date Received
    June 29, 2018
    Date of Event
    May 18, 2018
    Report Date
    November 24, 2019
    Manufacturer
    ORTHOPEDIATRICS, INC
    Product Code
    HWC
    UDI-DI
    0084113211102
    PMA / PMN Number
    K100240
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: UPDATED 01 OCT 2016. UPDATED METHOD 10, 4109, 4110 AND 3331. UPDATED RESULTS 3211. UPDATED CONCLUSION 4315. COMPLAINT SAMPLE WAS RETURNED FOR EVALUATION. REPORTED EVENT WAS NOT CONFIRMED. THERE WERE NO PROCESS DEVIATIONS THAT WOULD HAVE CONTRIBUTED TO THE FAILURE. THERE WERE NO RECENT DESIGN CHANGES PRIOR TO MANUFACTURING. RISK MANAGEMENT FILE REVIEW WAS DEEMED APPROPRIATE. ROOT CAUSE WAS UNABLE TO BE DETERMINED.

    Additional Manufacturer Narrative · 1

    REFERENCE: (B)(4). CONCOMITANT DEVICES - ITEM: 00-1050-7004, 3.5MM 80 DEGREE DFOS PLATE, 5 DEGREE FLARE, NO OFFSET, 4 HOLE, LOT: 171000-C; ITEM: 00-0903-2650, 3.5MM LOCKING CORTICAL SCREW, T15 HEX, 50MM, LOT: 162818-J - QUANTITY: 1; ITEM: 00-0903-2648, 3.5MM LOCKING CORTICAL SCREW, T15 HEX, 48MM, LOT: 160996-J; ITEM: 00-0903-2530, 3.5MM SELF TAPPING CORTICAL SCREW, T15 HEX, SIZE 30MM, LOT: 163725-J; ITEM: 00-0903-2534, 3.5MM SELF TAPPING CORTICAL SCREW, T15 HEX, SIZE 34MM, LOT: 164341-J; ITEM: 00-0903-2532, 3.5MM SELF TAPPING CORTICAL SCREW, T15 HEX, SIZE 32MM, LOT: 152163-J. THE COMPLAINT DEVICE HAS BEEN RETURNED, BUT THE DEVICE INVESTIGATION HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3006460162-2018-00043, 3006460162-2018-00044, AND 3006460162-2018-00046.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT FOLLOWING A SURGICAL PROCEDURE TO CORRECT A VALGUS DEFORMITY OF THE DISTAL FEMUR, THE IMPLANTED PLATE WAS FOUND TO HAVE SUBSIDED INTO FLEXION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE IT WAS DISCOVERED THAT THREE DISTAL LOCKING SCREWS HAD BENT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495426 ORTHOPEDIATRICS 3.5MM LOCKING CORTICAL SCREW, T15 HEX, 50MM LOCKING CORTICAL SCREW HWC ORTHOPEDIATRICS, INC N/A 162818-J 0084113211102

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention