BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEEK PREVAIL CERVICAL INTERBODY DEVICE

    MDR report key: 6157491 · Received December 9, 2016

    Report

    Report Number
    1030489-2016-03387
    Event Type
    Injury
    Date Received
    December 9, 2016
    Report Date
    December 8, 2016
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    ODP
    PMA / PMN Number
    K073285
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    DEVICES OF MULTIPLE PART/LOT NUMBERS WERE IMPLANTED DURING THE PROCEDURE INCLUDING: PART: 4210764 / LOT: UJ74 (X1) THE MANUFACTURER IS NOT SURE WHICH CAGE BACKED OUT. 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

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2014, PATIENT UNDERWENT CERVICAL ANTERIOR DECOMPRESSION FUSION AT LEVELS C2/3, C4/5 DUE TO PRE-OP DI AGNOSIS AS CERVICAL SPONDYLOSIS. ON AN UNKNOWN DATE, POST-OP, POOR SPINAL ALIGNMENT WAS OBSERVED DUE TO CAGE SUBSIDENCE. THE CAGE OF C4/5 AT CAUDAL SIDE WAS BACKED OUT. REVISION SURGERY, POSTERIOR DECOMPRESSION FUSION WAS PERFORMED FOR NEUROLOGIC SYMPTOM DUE TO POOR SPINAL ALIGNMENT. THERE WAS DELAY IN THE OVERALL PROCEDURE TIME BY MORE THAN 60 MINUTES. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    DATE OF REVISION SURGERY: (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809631 PEEK PREVAIL CERVICAL INTERBODY DEVICE INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL ODP MSD DEGGENDORF MFG NA ZF44

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention