BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTURE ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 9927453 · Received April 6, 2020

    Report

    Report Number
    1030489-2020-00420
    Event Type
    Injury
    Date Received
    April 6, 2020
    Report Date
    April 6, 2020
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWQ
    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

    OUTCOMES ATTRIBUTED TO ADVERSE EVENT: DURA INJURY. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG#: 9790317, 510K#: K042922, UDI#: (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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR FIXATION AT C2-C4 PERFORMED ACCF AND AT C4-C6 PERFORMED ACDF DUE TO OPLL(OSSIFICATION OF POSTERIOR LONGITUDINAL LIGAMENT). POST-OP, INJURY TO THE DURA OCCURRED DURING OPLL TRANSECTION. SPINAL FLUID LEAKAGE CONTINUED FOR A WHILE AFTER THE OPERATION, BUT THERE WERE NO SYMPTOMS, SO THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. AT THE POST-OPERATIVE FOLLOW-UP VISIT TO THE HOSPITAL ON (B)(6) 2020, IT WAS CHECKED THAT THE SCREW ON THE RIGHT SIDE OF C2 HAD BACKED OUT. HENCE, REVISION SURGERY FOR SCREW REMOVAL WAS PERFORMED ON THE SAME DAY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391336 VENTURE ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ MDT SOFAMOR DANEK PUERTO RICO MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other| R