BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LCP SUP ANT CLAVICLE PL W/LAT EXTN 5H/RT/94MM

    MDR report key: 4404342 · Received January 9, 2015

    Report

    Report Number
    3003506883-2015-10011
    Event Type
    Injury
    Date Received
    January 9, 2015
    Report Date
    December 16, 2014
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    PK111540
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT IT REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS LOT 6222813 OF 13.5MM LCP SUP ANT CLAVICLE PL W/ LAT EXTN 5H/RT/94MM WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK. A SINGLE PLATE WAS SCRAP AT FINAL INSPECTION FOR A VISUAL ANOMALY. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REVISION SURGERY TO THE RIGHT CLAVICLE FOR A NON-UNION ON (B)(6) 2014, IT WAS NOTED THAT THREE CORTEX SCREWS ON THE MEDIAL SIDE OF THE PLATE HAD PULLED OUT. ALL EXISTING IMPLANTS WERE REMOVED AND THE PATIENT WAS REVISED TO A NEW CLAVICLE PLATE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY TIME DELAY AND/OR ADDITIONAL MEDICAL/SURGICAL INTERVENTION. THE PATIENT OUTCOME WAS GOOD. THIS COMPLAINT INVOLVES EIGHT DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21201 3.5MM LCP SUP ANT CLAVICLE PL W/LAT EXTN 5H/RT/94MM PLATE, FIXATION, BONE HRS SYNTHES ELMIRA 6222813

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention