BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCULIF PL 10-16MM X11MM X 27 MM X 8 DEG CAGE

    MDR report key: 5174376 · Received October 24, 2015

    Report

    Report Number
    3004024955-2015-00085
    Event Type
    Injury
    Date Received
    October 24, 2015
    Date of Event
    September 28, 2015
    Report Date
    September 28, 2015
    Manufacturer
    STRYKER SPINE-US
    Product Code
    MAX
    PMA / PMN Number
    K143616
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT. RESULTS: THE REPORTED EVENT WAS CONFIRMED BASED ON THE IMAGES AND MEDICAL RECORDS PROVIDED. VISUAL AND FUNCTIONAL INSPECTIONS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED AND REMAINS IMPLANTED. A MANUFACTURING REVIEW OF THE DEVICE WAS PERFORMED AND INDICATED NO DISCREPANCIES OR ANOMALIES OF THE REPORTED DEVICE. CONCLUSION: THE COMBINATION OF ACTIVITY, PATIENT LIFESTYLE AND BMI WERE LIKELY CONTRIBUTING FACTORS OF EARLY DEVICE FAILURES FOR BOTH THE PRIMARY SURGERY AND REVISION SURGERY.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT. DEVICE WAS NOT RETURNED. RESULTS: IT WAS REPORTED THAT THE SECOND REVISION SURGERY TOOK PLACE. THE REASON FOR REVISION WAS IMPLANT MIGRATION AND COLLAPSE. A MANUFACTURING REVIEW OF THE DEVICE WAS PERFORMED AND INDICATED NO DISCREPANCIES OR ANOMALIES OF THE REPORTED DEVICE. CONCLUSION: THE COMBINATION OF ACTIVITY, PATIENT LIFESTYLE AND BMI WERE LIKELY CONTRIBUTING FACTORS OF EARLY DEVICE FAILURES FOR BOTH THE PRIMARY SURGERY AND REVISION SURGERY.

    Description of Event or Problem · 1

    THE DOCTOR NOTIFIED THE REP THAT THE PATIENT COMPLAINED OF PAIN AND IT STARTED IN THE POOL. X-RAYS NOTICED THAT THE ACCULIF GAGE HAD COLLAPSED. NO REVISION SURGERY SCHEDULED YET.

    Description of Event or Problem · 1

    THE DOCTOR NOTIFIED THE REP THAT THE PATIENT COMPLAINED OF PAIN AND IT STARTED IN THE POOL. X-RAYS NOTICED THAT THE ACCULIF GAGE HAD COLLAPSED. NO REVISION SURGERY SCHEDULED YET.

    Description of Event or Problem · 1

    THE DOCTOR NOTIFIED THE REP THAT THE PATIENT COMPLAINED OF PAIN AND IT STARTED IN THE POOL. X-RAYS NOTICED THAT THE ACCULIF GAGE HAD COLLAPSED. NO REVISION SURGERY SCHEDULED YET. UPDATE (12-MAY-2016). PATIENT HAD SECOND REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705934 ACCULIF PL 10-16MM X11MM X 27 MM X 8 DEG CAGE INTERVERTEBRAL BODY FUSION DEVICE MAX STRYKER SPINE-US 01271516

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention