BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACF DETACHABLE TRIAL SPACER LORDOTIC 6MM

    MDR report key: 3052004 · Received April 11, 2013

    Report

    Report Number
    3003787298-2013-00056
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 15, 2013
    Manufacturer
    SYNTHES JENNERSVILLE
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. THE DEVICE WAS NOT RECEIVED FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    DURING A C5-7 ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) SURGERY ON (B)(6) 2013, THE SURGEON WAS UNABLE TO GET THE ACF TRIAL SPACER HANDLE TO RELEASE THE TRIAL. HE MADE A SECOND ATTEMPT WITH A DIFFERENT TRIAL SPACER HANDLE AND THE OPPOSITE THING HAPPENED AND INSTRUMENT WOULD NOT LOAD THE TRIAL. THEREFORE, THE SURGEON WENT AHEAD AND PUT IN THE IMPLANT BY USING A BONE SPACER. THE SURGERY WAS PROLONGED FOR APPROXIMATELY 15 TO 20 MINUTES. NO ADVERSE EFFECT TO THE PATIENT WAS NOTED AND THE SURGEON WAS HAPPY WITH THE RESULTS. THIS IS 3 OF 3 REPORTS FOR THE SAME EVENT, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156536 ACF DETACHABLE TRIAL SPACER LORDOTIC 6MM LXH SYNTHES JENNERSVILLE 6554797

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention