BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEVO ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 9224098 · Received October 23, 2019

    Report

    Report Number
    1030489-2019-01193
    Event Type
    Injury
    Date Received
    October 23, 2019
    Date of Event
    September 24, 2019
    Report Date
    October 23, 2019
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWQ
    UDI-DI
    00643169327641
    PMA / PMN Number
    K141632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SPINAL CORD INJURY AND RUPTURE OF POSTERIOR WALL OF PATIENT'S VERTEBRAL BODY. 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. NOTE: THE FOLLOWING PRODUCTS WERE USED IN THE SURGERY. ALTHOUGH IT IS UNKNOWN WHETHER THE PRODUCT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILLING THIS MDR FOR NOTIFICATION PURPOSE. PART#G7783513; 510K#K141632; UDID# (B)(4), PART# G7783513; 510K# K141632; UDID#(B)(4), PART#G7783515; 510K#K141632; UDID#(B)(4), PART#G7783515; 510K#K141632; UDID#(B)(4), PART#G7783515; 510K#K141632; UDID#(B)(4), PART#G7783515; 510K#K141632; UDID#(B)(4), PART#3032028; 510K#EXEMPT PART#7080906; 510K#EXEMPT PART#3030007; 510K#EXEMPT PART#3032012; 510K#EXEMPT PART#3030007; 510K#EXEMPT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT :ANTERIOR CERVICAL DISCECTOMY AND FUSION DUE TO CERVICAL SPONDYLOTIC MYELOPATHY. INTRA-OPERATIVELY ,THERE WAS A POSSIBILITY OF SPINAL CORD INJURY BEYOND THE POSTERIOR WALL OF THE VERTEBRAL BODY AND RUPTURE OF POSTERIOR WALL OF PATIENT'S VERTEBRAL BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016725 ZEVO ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ WARSAW ORTHOPEDICS NA 0620902W 00643169327641

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other