BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASTERX EXPANDABLE CORPECTOMY SYSTEM

    MDR report key: 8387801 · Received March 4, 2019

    Report

    Report Number
    1030489-2019-00216
    Event Type
    Injury
    Date Received
    March 4, 2019
    Date of Event
    February 4, 2019
    Report Date
    April 4, 2019
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    MQP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 9050713, 510K #K011406, (B)(4) WAS CLEARED IN THE UNITED STATES. 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.

    Additional Manufacturer Narrative · 1

    X-RAY IMAGE REVIEW: POST-OP X-RAY FOR LUMBAR CORPECTOMY REVEALED A CHANGE IN ANGULATION OF THE INTERBODY GRAFT AT THE ADJACENT LEVELS. KYPHOPLASTY CEMENT IS PRESENT POSSIBLY AS A ADDITION FOR POOR BONE QUALITY. ONLY AP IMAGES ARE PROVIDED. LATERAL X-RAYS WOULD BE HELPFUL TO ASSESS DEFORMITY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PRE-OPERATIVE DIAGNOSIS: CORPECTOMIES LEVEL, IMPLANTED: L3 IT WAS REPORTED THAT 6 WEEKS POST-OP, X-RAY IMAGE WAS SHOWING THAT THE ENDPLATE OF THE CAGE HAS RELEASED AND MOVED. THE DOCTOR SUSPECTS A MECHANICAL PROBLEM WITH THE CAGE. THE PATIENT HAS MECHANICAL RESIDUAL SYMPTOMS AS COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180190 ASTERX EXPANDABLE CORPECTOMY SYSTEM SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP MSD DEGGENDORF MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other