BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ASNIS III CANNULATED SCREW

    MDR report key: 8976920 · Received September 9, 2019

    Report

    Report Number
    0008031020-2019-01260
    Event Type
    Injury
    Date Received
    September 9, 2019
    Date of Event
    January 1, 2014
    Report Date
    September 9, 2019
    Manufacturer
    STRYKER GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT HAS BEEN REPORTED DURING A LITERATURE REVIEW PERFORMED BY THE POST MARKET SURVEILLANCE GROUP. THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER ADDITIONAL INFORMATION IS AVAILABLE. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE AFFECTED LOT NUMBER WAS NOT COMMUNICATED. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    THE MANUFACTURER BECAME AWARE OF A POST-MARKET CLINICAL FOLLOW-UP (PMCF) REPORT FROM (B)(6). THE TITLE OF THIS REPORT IS ¿A POST-MARKET CLINICAL FOLLOW-UP (PMCF) OF THE TREATMENT OF FRACTURES OF SMALL AND LONG BONES AND OF THE PELVIS WITH THE ASNIS III CANNULATED SCREW SYSTEM¿ AND IS ASSOCIATED WITH THE STRYKER ASNIS III CANNULATED SCREW SYSTEM. WITHIN THAT PUBLICATION, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED WHICH OCCURRED BETWEEN (B)(6) 2014 AND (B)(6) 2018. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE CATALOG OR PATIENT DETAILS FROM THE REPORT, A REVIEW OF THE COMPLAINT HANDLING DATABASE, HOWEVER, REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED BY THE HOSPITAL OR BY THE AUTHOR OF THE PUBLICATION, THEREFORE 5 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES PAIN RELATED TO HARDWARE IRRITATION REQUIRING IMPLANT REMOVAL. 2 OUT OF 3 CASES. THE PMCF STATES, ¿THREE SUBJECTS EXPERIENCED PAIN RELATED TO THE HARDWARE IRRITATION REQUIRING IMPLANT REMOVAL WHICH WERE ALL RESOLVED ONCE THE IMPLANT WAS REMOVED. THE PAIN RELATED TO HARDWARE IRRITATION OCCURRED AT 233, 105, AND 1066 DAYS POST-SURGERY AND RESOLVED AT 246, 135, AND 1096 DAYS POST- SURGERY RESPECTIVELY.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770430 UNKNOWN ASNIS III CANNULATED SCREW IMPLANT HWC STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention