BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NCB FULLY THREAD.CANCEL.SCREW

    MDR report key: 2041283 · Received March 25, 2011

    Report

    Report Number
    9613350-2011-00180
    Event Type
    Injury
    Date Received
    March 25, 2011
    Report Date
    March 1, 2011
    Manufacturer
    ZIMMER GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS FORWARDED FROM THE OWNER ESTABLISHMENT ZIMMER INC., WHICH MARKETS THE DEVICES IN (B)(4). THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. WITH THE GIVEN INFORMATION, NO FURTHER INVESTIGATIONS ARE POSSIBLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER GMBH CONSIDERS THIS CASE CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT PT EXPERIENCED SHOULDER PAIN 2 YEARS POST-OP FROM A REVERSE SHOULDER ARTHROPLASTY. SURGEON OBTAINED X-RAYS OF RIGHT SHOULDER. ON X-RAY SURGEON COULD SEE A FRACTURE TM BASE PLATE POST ALONG WITH A BROKEN SCREW. SEEMS THAT THE PT FELL MONTHS AGO BUT DOESN'T REMEMBER. REVISION STATUS IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCB FULLY THREAD.CANCEL.SCREW NCB PLATING SYSTEM, PROXIMAL TIBIA PLATE HRS ZIMMER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other