BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2800440 · Received October 17, 2012

    Report

    Report Number
    2520274-2012-02284
    Event Type
    Injury
    Date Received
    October 17, 2012
    Report Date
    October 6, 2012
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A LOT A NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    DURING AN (B)(4) MEETING. SCIENTIFIC POSTER (B)(4) WAS PRESENTED: INCREASED NONUNION RATE AND DELAYED UNION OF DISTAL TIBIA FRACTURES TREATED WITH INTRAMEDULLARY NAILS AND ANGLE STABLE INTERLOCKING SCREWS. A REVIEW OF TWENTY TWO (22) PTS WITH DISTAL TIBIA FRACTURES (VARIOUS DEGREES) TREATED WITH INTRAMEDULLARY NAILING WITH ANY NUMBER OF ANGLE STABLE INTERLOCKING SCREWS (ASLS). SIXTEEN (16) PTS HAD SUFFICIENT F/U TO MEET INCLUSION CRITERIA AND WERE INCLUDED IN THE STUDY. PRIMARY OUTCOMES WERE COMPARED TO A HISTORICAL CONTROL GROUP FROM EXISTING PERTINENT LITERATURE THAT USED TRADITIONAL INTERLOCKING SCREWS. AVERAGE TIME UNTIL UNION WITH NO SECONDARY PROCEDURES: 30 WEEKS (RANGE: 11-56 WEEKS) AND WAS LONGER THAN POOLED CONTROLS: 16.2 - 23.5 WEEKS. THERE WERE 8 NONUNIONS (NU): POOLED CONTROLS IN LITERATURE: UNION 146 OF 163 PTS: 23. FIVE WEEKS WITH 10% NU RATE. STATISTICAL TREND TOWARD NU WITH MORE SEVERE OTA FRACTURE TYPE. NO DEEP INFECTIONS OR ASLS FAILURES IN THE STUDY GROUP. THERE WERE NO MAL-UNIONS. ONE FRACTURE WAS MALALIGNED AFTER INDEX PROCEDURE AND WENT ON TO A TRANSTIBIAL AMPUTATION FOR NU. THE STUDY GROUP REQUIRED A TOTAL OF 6 SECONDARY PROCEDURES. OF THE FRACTURES THAT HEALED PRIMARILY, MOST HEALED WITH LITTLE OR NO CALLUS FORMATION. THE RESULTS OF THE SMALL CLINICAL STUDY GROUP INDICATE A DISPROPORTIONATELY HIGH NU RATE AND PROLONGED UNION TIME COMPARED TO RESULTS OF SIMILAR FRACTURES TREATED WITH INTRAMEDULLARY NAILING UTILIZING STANDARD INTERLOCKING SCREWS. BASED ON OUR DATA WE HAVE STOPPED USING THESE IMPLANTS AND RECOMMEND CAUTIOUS USE OF ASLS TECHNOLOGY IN THIS FRACTURE PATTERN UNTIL HIGHER QUALITY DATA IS AVAILABLE. THERE WAS NO MENTION OF SYNTHES PRODUCT OR COMPETITOR PRODUCT IN THIS POSTER. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW HWC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NAIL| SCREW