BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 7873601 · Received September 13, 2018

    Report

    Report Number
    1030489-2018-01245
    Event Type
    Injury
    Date Received
    September 13, 2018
    Report Date
    January 9, 2019
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    MAX
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 9393008, 510K #K172199 AND UDI# (B)(4) WAS APPROVED FOR SALE IN THE UNITED STATES. H6: 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

    PRODUCT ANALYSIS: VISUAL, MICROSCOPIC AND DIMENSIONAL EVALUATION REVEALED THAT THE IMPLANT SHOWS SIGNS OF BEING BOTH IMPLANTED AND REMOVED. THERE IS NO CRACKING OR MATERIAL FAILURE NOTED TO THE IMPLANT. A CHECK OF OVERALL DIMENSIONS INDICATES THE IMPLANT IS THE CORRECT SIZE. AFTER REVIEW, THE IMPLANT DOES NOT APPEAR TO BE THE CAUSE OF THE ISSUE NOTED IN THE COMPLAINT. 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 WAS PRE-OPERATIVELY DIAGNOSED WITH SPINAL CANAL STENOSIS AND UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION(PLIF). POST-OP, THE SPACER WHICH WAS INSERTED AT L5/S DEVIATED BACKWARD, FOR WHICH THE ADDITIONAL SURGERY OR RE-OPERATION WAS PERFORMED ON (B)(6)2018. SLIGHT PAIN IN THE LOWER LIMBS WERE OBSERVED AS THE RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713824 CRESCENT SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MSD DEGGENDORF MFG NA 19DX

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other| R