BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOTODYNAMIC BONE STABILIZATION SYSTEM

    MDR report key: 7952916 · Received October 10, 2018

    Report

    Report Number
    3006845464-2018-00001
    Event Type
    Malfunction
    Date Received
    October 10, 2018
    Date of Event
    May 30, 2018
    Report Date
    May 30, 2023
    Manufacturer
    ILLUMINOSS MEDICAL, INC
    Product Code
    QAD
    PMA / PMN Number
    DEN160062
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING RE-SUBMITTED RETROSPECTIVELY PER FDA REQUEST. FROM 10 OCT 2018: INSTRUCTIONS AND SURGICAL TECHNIQUE GUIDE STATE TO REMOVE TEAR-AWAY SHEATH PRIOR TO BALLOON INFLATION AND CURING OF MONOMER. PHYSICIAN DID NOT FOLLOW THE INSTRUCTIONS FOR USE OR TRAINING ON DEVICE WHICH RESULTED IN FRAGMENT OF SHEATH REMAINING TRAPPED BETWEEN CURED IMPLANT AND BONE. USER ERROR WITH NO DEATH OR SERIOUS INJURY RESULTING. PLEASE NOTE THIS REPORT WAS RESUBMITTED ON 10OCT2018 BASED UPON CORRESPONDENCE WITH EMDR STAFF. EMDR WAS NOT ABLE TO BE LOADED AS SECTION D11 OF FORM WAS GREATER THAN 50 CHARACTERS IN LENGTH. EMDR STAFF REQUESTED WE TRUNCATE D11 AND RESUBMIT AND ADD EXPLANATORY NOTE IN H10.

    Description of Event or Problem · 0

    CASE INVOLVED A 20 Y/O FEMALE WITH A LEFT RADUS FRACTURE DUE TO A SUSPECTED PATHOLOGY OF FIBROUS DYSPLASIA. PHYSICIAN GAINED ACCESS TO THE INTRAMEDULLARY CANAL USING TECHNIQUE DESCRIBED IN PRODUCT LABELING WHICH INCLUDED INSERTION OF A GUIDEWIRE, SHEATH AND DILATOR. THE BALLOON IMPLANT WAS THEN PREPPED AND THE DILATOR AND WIRE REMOVED LEAVING THE SHEATH IN PLACE. THE BALLOON IMPLANT WAS A FEW MM LONG BUT DECIDED OT GO FORTH WITH THE PROCEDURE. THE BALLOON IMPLANT WAS INSERTED AND INFLATED WITH THE MONOMER. THE REP REPORTED THAT HE OBSERVED THE FLUOROGRAPHY SCREEN WHICH DEMONSTRATED EXCELLENT INFLATION PATTERN. THE RESIDENT ATTENDING THE CASE STATED THAT THE BALLOON HAD REACHED A POINT WHERE NO MORE MONOMER WAS REQUIRED. DURING THE CURING PROCESS IT WAS NOTICED THAT THE SHEATH HAD NOT BEEN REMOVED AS PER THE DEVICE'S INSTRUCTIONS FOR USE. THIS WAS NOTICED BY THE REP WHO INFORMED THE PHYSICIAN THAT REMOVAL OF THE SHEATH PRIOR TO INFLATION WAS REQUIRED. GIVEN THE INTERNAL PRESSURE OF THE INFLATED AND CURED IMPLANT IT WAS DIFFICULT TO REMOVE THE TEAR AWAY SHEATH AS PART WAS CONTAINED BETWEEN THE BALLOON AND THE MEDULLARY CANAL. ONLY APPROXIMATELY 2/3 WAS REMOVED LEAVING 1/3 IN THE PATIENT PINNED BETWEEN THE BALLOON AND BONE. THE PHYSICIAN MADE NO ATTEMPT TO REMOVE THE PIECE OF SHEATH REMAINING. THE SURGEON ACKNOWLEDGED THE MISTAKE AND AFTER THE PHYSICIAN MET WITH THE FAMILY THE REP SPOKE WITH THE PHYSICIAN WHO REPORTED THAT WHILE NOT IDEAL, HE DID NOT APPEAR OVERLY CONCERNED ABOUT THE SHEATH AND WAS HOPEFUL TO GET ROTATIONAL STABILITY GIVEN THE ADDITIONAL LAYER OF MATERIAL BETWEEN THE IMPLANT AND BONE. TO BE CONSERVATIVE, THE PHYSICIAN DECIDED TO CAST THE PATIENT AND WILL BE FOLLOWING-UP THE PATIENT. THE INSTRUCTIONS FOR USE CLEARLY STATE TO REMOVE THE TEAR AWAY SHEATH FROM THE CANAL, LEAVING THE BALLOON IN PLACE, BEFORE FILLING THE BALLOON WITH MONOMER. FOLLOW-UP REPORT INFORMATION: 1) PHYSICIAN STATED THAT AT TWO-WEEK FOLLOWUP PATIENT "WAS DOING FINE". 2) SALES REP. DISCUSSED THE PROCEDURE AGAIN WITH THE PHYSICIAN AND INCIDENT AT LENGTH FOLLOWING THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795416 PHOTODYNAMIC BONE STABILIZATION SYSTEM IN VIVO INTRAMEDUILLARY FIXATION ROD QAD ILLUMINOSS MEDICAL, INC 380176

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Female Other THE ILLUMINOSS SYSTEM INCLUDED ALL ACCESSORIES