BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUTRAK SCREW

    MDR report key: 8283692 · Received January 28, 2019

    Report

    Report Number
    3025141-2019-00050
    Event Type
    Malfunction
    Date Received
    January 28, 2019
    Report Date
    January 16, 2019
    Manufacturer
    ACUMED LLC
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MDR'S ASSOCIATED WITH THIS ARTICLE: 3025141-2019-00046: CASE 1; 3025141-2019-00047: CASE 2; 3025141-2019-00048: CASE 3; 3025141-2019-00049: CASE 4; 3025141-2019-00051: CASE 6; 3025141-2019-00052: CASE 7; 3025141-2019-00053: CASE 8; 3025141-2019-00054: CASE 9; 3025141-2019-00055: CASE 10; 3025141-2019-00056: CASE 11.

    Description of Event or Problem · 1

    FOLLOWING IMPLANTATION OF AN ACUTRAK SCREW, THE PATIENT DEVELOPED HETEROTROPIC OSSIFICATION WITH MINIMAL PROGRESSION ON SERIAL RADIOGRAPHS. NO REVISION SURGERY WAS REQUIRED. CASE 5. FROM: ARTICLE: OPEN REDUCTION AND INTERNAL FIXATION OF CAPITELLAR FRACTURES WITH HEADLESS SCREWS. RUCHELSMAN, DAVID E.; TEJWANI, NIRMAL C.; KWON, YOUNG W.; EGOL, KENNETH A. J BONE JOINT SURG AM. 2008; 90:1321-9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76734 ACUTRAK SCREW SCREW, FIXATION, BONE HWC ACUMED LLC

    Patients

    Seq Age Sex Outcome Treatment
    1