BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEVO ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 8178121 · Received December 19, 2018

    Report

    Report Number
    1030489-2018-01680
    Event Type
    Injury
    Date Received
    December 19, 2018
    Date of Event
    November 6, 2018
    Report Date
    January 4, 2019
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWQ
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. THE FOLLOWING MULTIPLE PRODUCTS WERE USED IN THE SURGERY: PART# , LOT# , QTY , SIMILAR DEVICE , 510K# , UPN: G3003057, 0529653W , 1 , NA , K141632 , (B)(4); G905H137, 0504991W, 1, 905-137 , K011406, (B)(4); G7703515, H5374458, 1 , NA , K141632 , (B)(4); G7703515 , H5374459, 1 , NA, K141632, (B)(4); G7703515, H5438715, 2, NA, K141632, (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THERE WAS NO MALFUNCTION WITH THE PLATE AND THE CAGE THEMSELVES. ON (B)(6) 2018, PATIENT UNDERWENT REVISION FOR EXCISION OF OPLL AGAIN (AT POSITION WHERE DECOMPRESSION WAS NOT ENOUGH). ONLY THE SCREW WAS REPLACED AND WAS FIXED. THE SPECIFIC DEVICE BY USING WHICH DURA GOT DAMAGED WAS UNKNOWN. IT WAS CONSIDERED THAT WHEN CUTTING OFF OSSIFICATION OF THE POSTERIOR LONGITUDINAL LIGAMENT (OPLL).

    Description of Event or Problem · 1

    PRE-OPERATIVE DIAGNOSIS FOR THIS INITIAL SURGERY: CERVICAL LAMINOPLASTY TO TREAT CERVICAL OSSIFICATION OF POSTERIOR LONGITUDINAL LIGAMENT PROCEDURE OF INITIAL SURGERY: CERVICAL LAMINOPLASTY UNILATERAL OPEN-DOOR AUTOGRAFT PRE-OPERATIVE DIAGNOSIS FOR REVISION: SPINAL CANAL STENOSIS DUE TO OSSIFICATION OF POSTERIOR LONGITUDINAL LIGAMENT (OPLL) REVISION PROCEDURE: ANTERIOR CERVICAL FIXATION AND FUSION WAS PERFORMED AT C4-6 IT WAS REPORTED THAT ON AN UNKNOWN DATE PATIENT UNDERWENT CERVICAL LAMINOPLASTY. POST-OP, PATIENT UNDERWENT REVISION SURGERY DUE TO SPINAL STENOSIS CAUSED BY OPLL. LEAKAGE OF SPINAL FLUID WAS OBSERVED AFTER THE REVISION SURGERY. AS A RESULT, PATIENT SUFFERED WITH PAIN IN THE HEAD. BONE FUSION WAS NOT COMPLETED BECAUSE IT WAS LESS THAN A MONTH AFTER THE INITIAL OPERATION. ADDITIONAL SURGERY WAS PLANNED TO PERFORM ON (B)(6) 2018. IT WAS PLANNED TO ONCE REMOVE THE IMPLANTED PLATE AND CAGE, AND THEN STOP THE SPINAL FLUID WHICH LEAKED FROM THE DURA WITH MEDICAL PASTE, THE CAGE AND PLATE WOULD BE IMPLANTED AND BE FIXED AGAIN. POSTOPERATIVE CT WAS IMAGED AND IT WAS CONFIRMED THAT THERE WAS NO CONTACT BETWEEN THE IMPLANTS AND THE SPINAL NERVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1018225 ZEVO ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R