BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERFACE

    MDR report key: 6011663 · Received October 7, 2016

    Report

    Report Number
    3005449756-2016-00001
    Event Type
    Injury
    Date Received
    October 7, 2016
    Date of Event
    September 8, 2016
    Report Date
    September 8, 2016
    Manufacturer
    BIOVENTUS LLC
    Product Code
    MQV
    PMA / PMN Number
    K112857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION AVAILABLE, THE ROOT CAUSE OF THE ISSUE IS LIKELY RELATED TO THE SURGICAL PROCEDURE AND NOT THE PRODUCT. IT IS DIFFICULT TO DETERMINE CAUSALITY BETWEEN THE HETEROTOPIC OSSIFICATION AND INTERFACE. HETEROTOPIC OSSIFICATION IS KNOWN TO BE A POTENTIAL ADVERSE EVENT WITH SPINAL FUSION PROCEDURES WHICH COULD HAVE OCCUR EVEN WITHOUT THE USE OF INTERFACE. THERE IS NO INFORMATION OR DATA RECEIVED TO DATE THAT SUGGESTS INTERFACE PROMOTES HETEROTOPIC OSSIFICATION. THIS IS THE FIRST REPORTED CASE OF HETEROTOPIC OSSIFICATION WITH INTERFACE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PHYSICIAN THAT HIS PATIENT UNDERWENT POSTEROLATERAL SPINAL FUSION SURGERY USING OSTEOMATRIX (SN (B)(4)) AND INTERFACE (SN (B)(4)) PRODUCTS. IT WAS NOTED THAT THE OSTEOMATRIX PRODUCT WAS HYDRATED AND THEN COVERED WITH THE INTERFACE PRODUCT PRIOR TO IMPLANT IN THE INTERVERTEBRAL RIGHT FORAMEN ON (B)(6) 2015. LATER, THE PATIENTS COMPLAINED OF BACK PAIN ON (B)(6) 2016 AND UNDERWENT EXPLORATORY BACK SURGERY ON (B)(6) 2016. DURING THE SURGICAL PROCEDURE, HETEROTOPIC OSSIFICATION WAS OBSERVED AND THE REMOVED. IT WAS NOTED THAT THE PHYSICIAN WAS VERY AWARE OF THE COMMONALITY BETWEEN HETEROTOPIC OSSIFICATION AND SPINAL FUSION PROCEDURES.

    Description of Event or Problem · 1

    CT SCAN IMAGES WERE PROVIDED TO THE MANUFACTURER FOR REVIEW. THE IMAGES CONFIRMED HETEROTOPIC OSSIFICATION AT THE IMPLANT SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663444 INTERFACE FILLER, BONE VOID, CALCIUM COMPOUND MQV BIOVENTUS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention