BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SCREW

    MDR report key: 9717230 · Received February 17, 2020

    Report

    Report Number
    3006460162-2020-00035
    Event Type
    Injury
    Date Received
    February 17, 2020
    Report Date
    February 17, 2020
    Manufacturer
    ORTHOPEDIATRICS, CORP
    Product Code
    HWC
    PMA / PMN Number
    K083286
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H6 PATIENT CODE: 1924. H6 DEVICE CODE: 1260. H6 METHOD CODE: 3331 - 4109. H6 RESULT CODE: 3252. H6 CONCLUSION CODE: 4315. D10 DEVICE AVAILABLE FOR EVALUATION: YES. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. PRODUCT EVALUATION CONFIRMED BROKEN SCREWS. THE PLATE WAS FOUND TO BE UNDAMAGED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED.

    Additional Manufacturer Narrative · 1

    REFERENCE: (B)(4). CONCOMITANT MEDICAL PRODUCTS- 4.5MM 90° DFOS PLATE, 5° FLARE, NO OFFSET, 4 HOLE: ITEM NUMBER; 00-1050-6004, LOT NUMBER; 162982-C. UNKNOWN LOCKING SCREW: ITEM NUMBER; UNKNOWN, LOT NUMBER; UNKNOWN QTY OF THREE (3). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL BE RETURNED TO ORTHOPEDIATRICS FOR INVESTIGATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3006460162-2020-00031, 3006460162-2020- 00032, 3006460162-2020-00033 AND 3006460162-2020-00034.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DFOS PLATE FAILED AND THE FOUR SCREWS BROKE. THE PATIENT WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181378 UNKNOWN SCREW PEDILOC, PLEO PEDILOC FEMUR HWC ORTHOPEDIATRICS, CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SEE H10