BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHIR ANTERIOR CERVICAL SYSTEM

    MDR report key: 6101326 · Received November 15, 2016

    Report

    Report Number
    1030489-2016-03128
    Event Type
    Injury
    Date Received
    November 15, 2016
    Report Date
    October 20, 2016
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PMA 510(K): THE PART IS NOT APPROVED FOR SALE IN THE US BUT A SIMILAR PART WITH CATALOGUE NUMBER 8799145 AND 510K NUMBER K994239 IS APPROVED FOR SALE IN THE US. (REVISION SURGERY). 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. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2016, PATIENT PRESENTED WITH PRE-OP DIAGNOSIS AS: CERVICAL SPONDYLOTIC MYELOPATHY AND HERNIATION. FOR WHICH PATIENT UNDERWENT ANTERIOR CERVICAL DISKECTOMY AND FUSION (ACDF) AT LEVELS C4-C7. POST-OP, A SCREW OF CERVICAL PLATE WHICH WAS USED AT ANTERIOR CERVICAL FUSION AT CAUDAL CAME OUT AND THE PLATE WAS DISLOCATED. DUE TO WHICH PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2016. IN WHICH THE PLATE AT ANTERIOR WAS REMOVED AND POSTERIOR FUSION WAS PERFORMED AT C4/C7. THERE WAS A DELAY OF MORE THAN 60 MIN IN THE PROCEDURE. THE PRODUCTS CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AFTER REVISION SURGERY. DOCTOR'S COMMENT: THE PATIENTS BONE WAS FRAGILE. SO, THE SCREW COULDN'T ACHIEVE FIRM ENGAGEMENT WITH IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754184 ZEPHIR ANTERIOR CERVICAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ WARSAW ORTHOPEDICS NA 0060038W

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention