BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLIM-LOC ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 3260167 · Received August 1, 2013

    Report

    Report Number
    1526439-2013-22288
    Event Type
    Injury
    Date Received
    August 1, 2013
    Date of Event
    April 1, 2011
    Report Date
    July 9, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    KWQ
    PMA / PMN Number
    PK013877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. DEVICE NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE PRODUCT SAMPLE WAS NOT RETURNED FOR EVALUATION AS IT WAS RETAINED INSIDE THE PATIENT AS A STANDARD OF CARE. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED AS THE LOT NUMBER OF THE PRODUCT WAS UNKNOWN AND LEFT INSIDE THE PATIENT. THERE WAS NO FAILURE OF THE IMPLANT NOTED IN THE COMPLAINT. FURTHER DEGRADATION OF THE SPINE IS A KNOWN RISK ASSOCIATED WITH ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) AS STATED IN THE INTRODUCTION OF ¿PRODISC-C AND ANTERIOR CERVICAL DISCECTOMY AND FUSION AS SURGICAL TREATMENT FOR SINGLE-LEVEL CERVICAL SYMPTOMATIC DEGENERATIVE DISC DISEASE. WITHOUT A PRODUCT SAMPLE, WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE, AND THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF THE COMPLAINT PRODUCT SAMPLE BECOMES AVAILABLE, THE COMPLAINT FILE WILL BE REOPENED AND PRODUCT EVALUATED.

    Description of Event or Problem · 1

    PREOPERATIVE DIAGNOSIS: CERVICAL DISC DISEASE. IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN AND UNDERWENT A REVISION CERVICAL SURGICAL PROCEDURE AT AN ADJACENT LEVEL (DEGENERATIVE DISC DISEASE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359855 SLIM-LOC ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention