BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESTIGE CERVICAL DISC SYSTEM

    MDR report key: 6101351 · Received November 15, 2016

    Report

    Report Number
    1030489-2016-03142
    Event Type
    Injury
    Date Received
    November 15, 2016
    Report Date
    July 19, 2017
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    MJO
    UDI-DI
    00613994493705
    PMA / PMN Number
    P090029
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMAGE REVIEW: POST-OP X-RAYS AND MRI PROVIDED FOR C5-6 PRESTIGE LP DISC REPLACEMENT SHOWS GRAFT IMPROPERLY POSITIONED ON X-RAY IN THE INTERBODY SPACE. MRI SHOWS EXTENSIVE ARTIFACT BUT PROBABLY SOME CENTRAL CANAL STENOSIS. THE RIGHT C5-6 NEURAL FORAMEN IS NOT SEEN. SUSPECT INCOMPLETE DECOMPRESSION OF DISC SPACE AND FORAMEN WITH INADEQUATE PREPARATION OF END PLATE ANATOMY FOR DEVICE PLACEMENT.

    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

    (B)(4). 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.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: DEVICE MEETS SPECIFICATIONS. NO DEFECTS OBSERVED DURING VISUAL ANALYSIS OR THROUGH DIMENSIONAL AND FUNCTIONAL CHECKS. 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) 2015 PATIENT UNDERWENT SURGERY. POST-OP, PATIENT SUFFERED WITH RADICULOPATHY AND SURGEON SUSPECTS CONTINUED CERVICAL STENOSIS. FOLLOWING INITIAL IMPLANT, SYMPTOMS OF RIGHT ARM PAIN, NUMBNESS, TINGLING AND WEAKNESS PERSISTED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THE PRODUCT DIDN'T BREAK. ON (B)(6) 2016, PATIENT UNDERWENT REVISION SURGERY AT LEVELS C5/6 WITH PRIMARY DIAGNOSIS FOR REVISION SURGERY AS C5/6 RADICULOPATHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752389 PRESTIGE CERVICAL DISC SYSTEM PROSTHESIS, INTERVERTEBRAL DISC MJO WARSAW ORTHOPEDICS NA 0335300W 00613994493705

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention