BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM X 8MM FULLY THREADED SCREW, ANGLED LOCKING

    MDR report key: 7823991 · Received August 28, 2018

    Report

    Report Number
    2027754-2018-00029
    Event Type
    Malfunction
    Date Received
    August 28, 2018
    Date of Event
    February 9, 2018
    Report Date
    August 24, 2018
    Manufacturer
    OSTEOMED
    Product Code
    HWC
    UDI-DI
    00845694023528
    PMA / PMN Number
    K090522
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICES WERE NOT RETURNED. THEREFORE, AN EVALUATION COULD NOT BE PERFORMED. THE LOT NUMBER WAS UNKNOWN. THEREFORE, A REVIEW OF THE SPECIFIC DHRS FOR THE DEVICES ASSOCIATED WITH THIS COMPLAINT COULD NOT BE PERFORMED. A TWO-YEAR REVIEW OF COMPLAINTS WAS PERFORMED. THE REVIEW SHOWS THAT THE THIS IS THE ONLY COMPLAINT RECEIVED WITHIN THE LAST 2 YEARS FOR ALL THE DEVICES REFERENCED EXCEPT P/N 330-2014 AND P/N 331-2012. BOTH OF THESE DEVICES HAD ONE ADDITIONAL COMPLAINT FOR A BROKEN SCREW HEAD. BUT NEITHER OF THE COMPLAINTS RESULTED IN AN ADVERSE EVENT. FOR EACH SYSTEM THAT THESE IMPLANTS ARE PART OF, THERE IS A DOCUMENTED RISK DOCUMENT THAT ADDRESSES MULTIPLE SITUATIONS THAT COULD CAUSE/CONTRIBUTE TO IMPLANT FAILURE. HOWEVER, WITHOUT THE DETAILS OF WHY THE DEVICES WERE EXPLANTED, WE ARE UNABLE TO CONFIRM THAT THE FAILURE MODES HAVE BEEN ASSESSED. EACH SYSTEM ALSO HAS AN IFU THAT ADDRESSES MULTIPLE WARNINGS, CONTRAINDICATIONS, AND SITUATIONS THAT COULD CAUSE/CONTRIBUTE TO IMPLANT FAILURE. WITHOUT THE DETAILS OF WHY THE DEVICES WERE EXPLANTED, WE ARE UNABLE TO CONFIRM THAT THE OSTEOMED LABELING ADDRESSES ISSUE EXPERIENCED. THEREFORE, A FULL INVESTIGATION COULD NOT BE COMPLETED. SHOULD OSTEOMED RECEIVE ADDITIONAL INFORMATION TO CONDUCT A FULL INVESTIGATION, AN AMENDMENT TO THIS REPORT WILL BE ADDED.

    Description of Event or Problem · 0

    OSTEOMED WAS NOTIFIED OF AN INCIDENT RELATED TO A PATIENT. PER THE INFORMATION RECEIVED, THE PATIENT RECEIVED IMPLANTS ON 08/31/2017. THE LISTING OF IMPLANTS WERE PROVIDED. THE IMPLANTS WERE REMOVED ON 02/09/2018. NO ADDITIONAL INFORMATION WAS RECEIVED. FOLLOWING A SEARCH TO DETERMINE IF THE INCIDENT HAD BEEN PREVIOUSLY REPORTED, IT WAS DETERMINED THAT PRIOR NOTIFICATION WAS NOT IN OUR SYSTEM. THEREFORE, A COMPLAINT FOR EACH PART NUMBER REFERENCED HAS BEEN INITIATED TO DOCUMENT THIS INCIDENT AS AN ADVERSE EVENT.

    Description of Event or Problem · 1

    ON (B)(4) 2018, OSTEOMED WAS NOTIFIED OF AN ADVERSE EVENT RELATED TO A PATIENT. PER THE INFORMATION RECEIVED, THE PATIENT RECEIVED IMPLANTS ON (B)(6) 2017. THE IMPLANTS WERE REMOVED ON (B)(6) 2018. NO ADDITIONAL INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666291 2.0MM X 8MM FULLY THREADED SCREW, ANGLED LOCKING HAND PLATING SYSTEM HWC OSTEOMED UNKNOWN 00845694023528

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention