BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTURE ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 5969434 · Received September 22, 2016

    Report

    Report Number
    1030489-2016-02627
    Event Type
    Injury
    Date Received
    September 22, 2016
    Report Date
    September 1, 2016
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THESE PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, THE CATALOG #S 9791223 AND 510K # K061274 OF 'LIKE DEVICES' WERE CLEARED IN THE UNITED STATES. (B)(6). 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. DEVICES OF MULTIPLE PART/LOT NUMBERS WERE IMPLANTED DURING THE PROCEDURE INCLUDING: PART: G905H137 / LOT: 0267204W PART: G9791323 / LOT: H5088384 PART: G9791323 / LOT: H5107044 PART: G9791223 / LOT: H5176664 ALTHOUGH IT IS UNKNOWN IF ANY OF THESE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Additional Manufacturer Narrative · 1

    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 CERVICAL ANTERIOR DECOMPRESSION AND FUSION AT LEVELS: C3-7. PATIENT WAS IMPLANTED WITH MESH AND CERVICAL PLATE. ON (B)(6) 2016 (DATE IS APPROX), PATIENT WAS IMPLANTED WITH 4 SCREWS. POST-OP, SCREW MIGRATED. AN IMAGE TAKEN ON (B)(6) 2016 (DATE IS APPROX.) SHOWED ONLY 3 SCREWS. A HOLE WAS FOUND ON THE ESOPHAGUS. ON (B)(6) 2016, PATIENT UNDERWENT REVISION SURGERY DUE TO PRE-OP DIAGNOSIS AS PERFORATION OF ESOPHAGUS DUE TO IMPLANT MIGRATION. ALL THE IMPLANTS WERE EXPLANTED AND ILIAC BONE WAS TRANSPLANTED. AFTER IMPLANT REMOVAL, AUTOGENOUS BONE WAS GRAFTED. PATIENT DIDN'T ACHIEVE SOLID FUSION AND THIS IS CONSIDERED AS A REASON FOR MIGRATION OF SCREW. THERE WAS A DELAY OF MORE THAN 60 MINUTES DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622564 VENTURE ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ MDT SOFAMOR DANEK PUERTO RICO MFG NA H5176664

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention