BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHIR ANTERIOR CERVICAL SYSTEM

    MDR report key: 6851040 · Received September 8, 2017

    Report

    Report Number
    1030489-2017-02012
    Event Type
    Injury
    Date Received
    September 8, 2017
    Date of Event
    August 14, 2017
    Report Date
    January 4, 2018
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    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

    THIS PART IS NOT APPROVED FOR USE IN THE US, HOWEVER A LIKE DEVICE WITH PART# 8792113, 510K# K994239 AND (B)(4) IS CLEARED FOR US. PRODUCT WAS NOT 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: THE PLATE AND FOUR BONE SCREWS WHERE RETURNED. THE BOTH LOCKING TABS HAVE BEEN BROKEN OFF ONE SIDE OF THE PLATE. ON ONE OF THE BONES SCREWS (LOT# H5174732) HAS CLEAR WITNESS MARKS WHERE IT IS PUSHED UPWARDS AGAINST THE TAB AND BROKE IT. ANOTHER SCREW ALSO LOT# H5174732 HAS WITNESS MARKS AROUND THE MINOR DIAMETER OF THE SCREW INDICATING THAT SCREW MAY NOT HAVE BEEN AT THE PERFECT ANGLE DURING IMPLANTATION. THERE DOES NOT APPEAR TO BE A MANUFACTURING ISSUE WITH THE SCREWS OR THE PLATE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DATE OF INITIAL SURGERY: (B)(6) 2015 PROCEDURE USED IN INITIAL SURGERY: C5/6: ANTERIOR CERVICAL DECOMPRESSION FUSION PRE-OP DIAGNOSIS FOR REVISION: ONE SCREW BACK OUT PROCEDURE USED IN REVISION: ANTERIOR CERVICAL DECOMPRESSION FUSION, C5/6 IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGERY AT C5/6 IN WHICH THE PLATE WAS IMPLANTED. POST-OP, AFTER APPROXIMATELY SIX MONTHS ONE SCREW BACKED-OUT. PATIENT UNDERWENT REVISION SURGERY FOR REPLACEMENT OF THE SCREW. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631802 ZEPHIR ANTERIOR CERVICAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA H12V0320

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention