BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DYNAMIC JOINT DISTRACTOR II EXTERNAL FIXATOR

    MDR report key: 15089324 · Received July 22, 2022

    Report

    Report Number
    0008031020-2022-00362
    Event Type
    Injury
    Date Received
    July 22, 2022
    Date of Event
    May 8, 2017
    Report Date
    August 29, 2022
    Manufacturer
    STRYKER GMBH
    Product Code
    KTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT HAS BEEN GENERATED BASED ON FINDINGS DISCOVERED DURING POST MARKET SURVEILLANCE LITERATURE REVIEW. THE ALLEGED EVENT REGARDING RADIAL NERVE PALSY, SEVERE AXONOTMESIS, AND TOTAL LOSS OF RADIAL NERVE FUNCTION 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. DEVICE DISPOSITION UNKNOWN.

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT HAS BEEN GENERATED BASED ON FINDINGS DISCOVERED DURING THE POST-MARKET SURVEILLANCE LITERATURE REVIEW. THE ALLEGED EVENT OF COMPLETE RADIAL NERVE PALSY, IN THE IMMEDIATE POST-OPERATIVE PERIOD. EIGHT WEEKS FOLLOWING EXTERNAL FIXATOR, SEVERE AXONOTMESIS WAS REVEALED, AND SIX MONTHS POST-OPERATIVELY, TOTAL LOSS OF RADIAL NERVE FUNCTION PERSISTED. A TENDON TRANSFER WAS PROPOSED, BUT PATIENT REFUSED FURTHER SURGICAL TREATMENT 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 ¿ORTHOPAEDIC DEPARTMENT, SERVICIO CIRUGI´A ORTOPE´DICA, HOSPITAL SANTA CRUZ Y SAN PABLO, BARCELONA AUTONOMA UNIVERSITY, SPAIN ¿. THE TITLE OF THIS REPORT IS ¿RADIAL NERVE INJURY FOLLOWING ELBOW EXTERNAL FIXATOR: REPORT OF THREE CASES AND LITERATURE REVIEW ¿, PUBLISHED ON (B)(6)2017, AND CAN BE FOUND AT DOI 10.1007/S00402-017-2711-1. THE REPORT IS ASSOCIATED WITH THE STRYKER ¿DYNAMIC JOINT DISTRACTOR II EXTERNAL FIXATION SYSTEM¿ AND INCLUDES AN ANALYSIS OF THE CLINICAL DATA THAT WAS COLLECTED ON 3 PATIENTS. DURING THE REVIEW OF THE LITERATURE, IT WAS NOT POSSIBLE TO ESTABLISH A PRECISE DEVICE(S) IDENTIFICATION OR PATIENT INFORMATION; HOWEVER, THE ARTICLE ALLEGES THAT ONE (1) PATIENT EXPERIENCED COMPLETE RADIAL NERVE PALSY, IN THE IMMEDIATE POST-OPERATIVE PERIOD. EIGHT WEEKS FOLLOWING EXTERNAL FIXATOR, SEVERE AXONOTMESIS WAS REVEALED, AND SIX MONTHS POST-OPERATIVELY, TOTAL LOSS OF RADIAL NERVE FUNCTION PERSISTED. A TENDON TRANSFER WAS PROPOSED, BUT PATIENT REFUSED FURTHER SURGICAL TREATMENT.

    Description of Event or Problem · 0

    THE MANUFACTURER BECAME AWARE OF A LITERATURE PUBLISHED BY THE ¿ORTHOPAEDIC DEPARTMENT, SERVICIO CIRUGI´A ORTOPE´DICA, HOSPITAL SANTA CRUZ Y SAN PABLO, BARCELONA AUTONOMA UNIVERSITY, SPAIN ¿. THE TITLE OF THIS REPORT IS ¿RADIAL NERVE INJURY FOLLOWING ELBOW EXTERNAL FIXATOR: REPORT OF THREE CASES AND LITERATURE REVIEW ¿, PUBLISHED ON MAY 08, 2017, AND CAN BE FOUND AT DOI 10.1007/S00402-017-2711-1. THE REPORT IS ASSOCIATED WITH THE STRYKER ¿DYNAMIC JOINT DISTRACTOR II EXTERNAL FIXATION SYSTEM¿ AND INCLUDES AN ANALYSIS OF THE CLINICAL DATA THAT WAS COLLECTED ON 3 PATIENTS. DURING THE REVIEW OF THE LITERATURE, IT WAS NOT POSSIBLE TO ESTABLISH A PRECISE DEVICE(S) IDENTIFICATION OR PATIENT INFORMATION; HOWEVER, THE ARTICLE ALLEGES THAT ONE (1) PATIENT EXPERIENCED COMPLETE RADIAL NERVE PALSY, IN THE IMMEDIATE POST-OPERATIVE PERIOD. EIGHT WEEKS FOLLOWING EXTERNAL FIXATOR, SEVERE AXONOTMESIS WAS REVEALED, AND SIX MONTHS POST-OPERATIVELY, TOTAL LOSS OF RADIAL NERVE FUNCTION PERSISTED. A TENDON TRANSFER WAS PROPOSED, BUT PATIENT REFUSED FURTHER SURGICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117584 UNKNOWN DYNAMIC JOINT DISTRACTOR II EXTERNAL FIXATOR APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other