BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN APEX PINS

    MDR report key: 15069904 · Received July 20, 2022

    Report

    Report Number
    0008031020-2022-00350
    Event Type
    Injury
    Date Received
    July 20, 2022
    Date of Event
    September 18, 2020
    Report Date
    August 24, 2022
    Manufacturer
    STRYKER GMBH
    Product Code
    JDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS RECORD IS A CONSOLIDATION OF EVENTS SUMMARIZED AS PART OF LITERATURE REVIEW WHEN DEVICE AND PATIENT INFORMATION IS NOT AVAILABLE. THIS COMPLAINT HAS BEEN GENERATED BASED ON FINDINGS DISCOVERED DURING POST MARKET SURVEILLANCE LITERATURE REVIEW. THE ALLEGED EVENT OF PIN INFECTIONS COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR. MORE DETAILED INFORMATION ABOUT THE PATIENT MEDICAL HISTORY, THE EVENT CIRCUMSTANCES, RADIOGRAPHS AND THE INVOLVED DEVICE(S) MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE REOPENED AND RE-EVALUATED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    PLEASE NOTE CORRECTION TO SUSPECTED MEDICAL DEVICE IN SECTION D. THIS INCLUDES THE FOLLOWING; PRODUCT LONG DESCRIPTION, PRODUCT CODE, AND COMMON DEVICE NAME. THIS COMPLAINT HAS BEEN GENERATED BASED ON FINDINGS DISCOVERED DURING THE POST-MARKET SURVEILLANCE LITERATURE REVIEW. THE ALLEGED EVENT OF PIN INFECTIONS COULD NOT BE CONFIRMED, SINCE NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR OR THE ARTICLE. MORE DETAILED INFORMATION ABOUT THE PATIENT MEDICAL HISTORY, THE EVENT CIRCUMSTANCES, AND MEDICAL REPORTS MUST BE AVAILABLE TO DETERMINE THE ROOT CAUSE. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE REOPENED AND RE-EVALUATED ACCORDINGLY.

    Description of Event or Problem · 0

    THE MANUFACTURER BECAME AWARE OF A LITERATURE PUBLISHED BY THE ¿DEPARTMENT FOR INTERNAL MEDICINE III, MATHIAS-SPITAL RHEINE, GERMANY¿. THE TITLE OF THIS REPORT IS, ¿LONG-TERM OUTCOME OF PERSONS WITH DIABETIC AND NON-DIABETIC NEURO-OSTEOARTHROPATHY AFTER FOOT CORRECTION USING EXTERNAL FIXATION¿, PUBLISHED ON SEPTEMBER 18, 2020, WHICH IS ASSOCIATED WITH THE STRYKER ¿HOFFMANN II EXTERNAL FIXATION SYSTEM¿. THE ARTICLE CAN BE FOUND AT HTTPS://DOI.ORG/10.1111/DME.14404. THIS REPORT INCLUDES AN ANALYSIS OF THE CLINICAL DATA THAT WAS COLLECTED ON 115 PATIENTS, AND THE CASES IN THIS STUDY RANGE FROM JULY 2008 TO DECEMBER 2012. DURING THE REVIEW OF THE LITERATURE, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND CURRENTLY NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE. IT WAS REPORTED THAT 16 PATIENTS EXPERIENCED PIN INFECTIONS. THE ARTICLE STATES, ¿TWENTY-ONE COMPLICATIONS OCCURRED AFTER IMPLANTATION OF THE EXTERNAL FIXATOR, OF WHICH 16 WERE PIN INFECTIONS AND TWO WERE DELAYED WOUND HEALING. THERE WAS NO MORTALITY WITHIN 30 DAYS OF SURGERY¿.

    Description of Event or Problem · 0

    THE MANUFACTURER BECAME AWARE OF A LITERATURE PUBLISHED BY THE ¿DEPARTMENT FOR INTERNAL MEDICINE III, MATHIAS-SPITAL RHEINE, GERMANY¿. THE TITLE OF THIS REPORT IS, ¿LONG-TERM OUTCOME OF PERSONS WITH DIABETIC AND NON-DIABETIC NEURO-OSTEOARTHROPATHY AFTER FOOT CORRECTION USING EXTERNAL FIXATION¿, PUBLISHED ON SEPTEMBER 18, 2020, WHICH IS ASSOCIATED WITH THE STRYKER ¿HOFFMANN II EXTERNAL FIXATION SYSTEM¿. THE ARTICLE CAN BE FOUND AT HTTPS://DOI.ORG/10.1111/DME.14404. THIS REPORT INCLUDES AN ANALYSIS OF THE CLINICAL DATA THAT WAS COLLECTED ON 115 PATIENTS, AND THE CASES IN THIS STUDY RANGE FROM JULY 2008 TO DECEMBER 2012. DURING THE REVIEW OF THE LITERATURE, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND CURRENTLY NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE. IT WAS REPORTED THAT 16 PATIENTS EXPERIENCED PIN INFECTIONS. THE ARTICLE STATES, ¿TWENTY-ONE COMPLICATIONS OCCURRED AFTER IMPLANTATION OF THE EXTERNAL FIXATOR, OF WHICH 16 WERE PIN INFECTIONS AND TWO WERE DELAYED WOUND HEALING. THERE WAS NO MORTALITY WITHIN 30 DAYS OF SURGERY ¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358471 UNKNOWN APEX PINS PIN, FIXATION, THREADED JDW STRYKER GMBH UNKNOWN
    416883 UNKNOWN APEX PINS PIN, FIXATION, THREADED JDW STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other