BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 9909230 · Received April 1, 2020

    Report

    Report Number
    1030489-2020-00404
    Event Type
    Malfunction
    Date Received
    April 1, 2020
    Date of Event
    March 9, 2020
    Report Date
    April 1, 2020
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    MAX
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 9393007, 510K # K172199, UDI # (B)(4) WAS CLEARED IN THE UNITED STATES. PRODUCT WAS NOT 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

    PRE OP DIAGNOSIS: BACK PAIN PROCEDURE PERFORMED: TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) LEVELS IMPLANTED: L4/5 AND L5/S1 INTRA OP,TIP OF THE DEVICE BROKE OFF. SURGEON CHOSE TO LEAVE THE REMAINING IMPLANT IN PATIENT. SURGEON WAS USING THE BALL TIP TAMP AND FELT MALLET TOO HARD ON IMPLANT CAUSING THE TIP TO BREAK OFF. THERE WERE NO COMPLICATIONS TO THE PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374192 CRESCENT SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MSD DEGGENDORF MFG NA XF47

    Patients

    Seq Age Sex Outcome Treatment
    1