BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING PROXIMAL FEMORAL PLATE, 150 DEGREE, 4.5MM, 5-HOLE

    MDR report key: 8601370 · Received May 10, 2019

    Report

    Report Number
    3006460162-2019-00017
    Event Type
    Injury
    Date Received
    May 10, 2019
    Report Date
    November 26, 2019
    Manufacturer
    ORTHOPEDIATRICS, INC
    Product Code
    HRS
    UDI-DI
    00841132104620
    PMA / PMN Number
    K111086
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: D7 UPDATED 04 APR 2019. H4 UPDATED 07 FEB 2012. H6 UPDATED METHOD 10, 3331, 4109 AND 4110. H6 UPDATED RESULTS 3211. H6 UPDATED CONCLUSION 4315. COMPLAINT SAMPLE WAS RETURNED FOR EVALUATION. REPORTED EVENT WAS CONFIRMED. THE DHR WAS REVIEWED AND 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. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED.

    Additional Manufacturer Narrative · 1

    REFERENCE: (B)(4). DEVICE EVALUATED BY MFR: PRODUCT HAS NOT BEEN RETURNED TO ORTHOPEDIATRICS FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING THE PLACEMENT OF A LOCKING PROXIMAL FEMORAL PLATE, THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO FRACTURED PROXIMAL SCREWS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394500 LOCKING PROXIMAL FEMORAL PLATE, 150 DEGREE, 4.5MM, 5-HOLE PLATE, FIXATION, BONE HRS ORTHOPEDIATRICS, INC N/A M31259 00841132104620

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention