BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUFIX

    MDR report key: 1445154 · Received August 19, 2009

    Report

    Report Number
    1649384-2009-00300
    Event Type
    Injury
    Date Received
    August 19, 2009
    Report Date
    August 19, 2009
    Manufacturer
    ZIMMER SPINE
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IS STILL IMPLANTED. DEVICE MANUFACTURE DATE IS UNK. EVALUATION IS PENDING.

    Description of Event or Problem · 1

    ON 07/28/2009, THE SALES REP REPORTED THAT ON AN UNK DATE, THE DOCTOR'S OFFICE HAD REQUESTED AN ACUFIX PLATE AND SCREW FOR ALLERGY TESTING. IN 2008, THE PT WAS IMPLANTED WITH ACUFIX SLIMLINE PRODUCT IN C5-C7 AREA. ON AN UNK DATE, THE PT'S PRIMARY PHYSICIAN SUSPECTED THAT THE PT WAS HAVING AN ALLERGIC REACTION TO THE IMPLANTS. IT IS UNK WHAT THE PT SYMPTOMS ARE. THE SALES REP GAVE THE SURGEON A 403-1122 AND 402-43112 IMPLANT TO PERFORM ALLERGY TESTING. AT THIS TIME, NO REVISION SURGERY HAS BEEN PERFORMED, NOR SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUFIX ACUFIX KWQ ZIMMER SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other SCREW| 402-43112 - SC-ACUFIX SELF TAPPING 4.0MM WIDE ROOT| 403-1122 - SLIMLINE SPIKELESS PLATE