BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KT GRAFT 10ML STIMULAN

    MDR report key: 17572292 · Received August 17, 2023

    Report

    Report Number
    MW5144718
    Event Type
    Injury
    Date Received
    August 17, 2023
    Report Date
    August 16, 2023
    Manufacturer
    BIOCOMPOSITES LTD.
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    EVENT DESCRIPTION: ON OR ABOUT (B)(6) 2022 THE PATIENT SUSTAINED INJURIES AS A RESULT OF TRIP AND FALL OVER A SECURITY BAND ON THE EXTERIOR SIDEWALK PREMISES OF THE STORE. ON OR ABOUT (B)(6) 2022 THE SURGEON PERFORMED A RIGHT FEMUR DISTAL FRACTURE SURGICAL REPAIR. ON OR ABOUT (B)(6) OF 2023 THE PATIENT UNDERWENT SECOND SURGERY TO REPLACE THE (B)(6) HARDWARE INSTALLED DUE TO INFECTION RELATED TO SURGERY, (B)(6) HARDWARE WAS DEFECTIVE IN DESIGN AND/OR MANUFACTURE AND PAST AND PRESENT PAIN AND SUFFERING HE ALLEGEDLY SUSTAINED. THIS COMPLAINT INVOLVES UNKNOWN NUMBER OF DEVICES. REFERENCE REPORTS: MW5144705, MW5144706, MW5144707, MW5144708, MW5144709, MW5144710, MW5144711, MW5144712, MW5144713, MW5144714, MW5144715, MW5144716, MW5144717, MW5144719, MW5144720, MW5144721, MW5144722, MW5144723, MW5144724, MW5144725, MW5144726, MW5144727, MW5144728, MW5144729, MW5144730. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2332749 KT GRAFT 10ML STIMULAN FILLER, BONE VOID, CALCIUM COMPOUND MQV BIOCOMPOSITES LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 29 HOLE RIGHT BROAD PLATE.| CHIPS 30ML 4-10MM CANC.| KT GRAFT 20ML STIMULAN.| KWIRE TROCAR TIP.| MATRIX 10ML VIVIGEN LRG.| NAIL FEM RETROGRADE.| SCREW 5X42MM LOCK T2.| SCREW 5X42MM LOCK T2.| SCREW 5X50MM LOCK T2.| SCREW 5X80MM.| SCREW 5X85.5MM LOCK T2.| SCREW CORTICAL 3.5X34MM.| SCREW CORTICAL.| SCREW LOCK 3.5X48MM.| SCREW LOCK 4.0X40MM.| SCREW LOCK 4.0X50MM.| SCREW LOCK 4.5X44MM.| SCREW LOCK 4.5X46MM.| SCREW LOCK 4.5X48MM.| SCREW LOCK 4.5X90MM.| SCREW LOCK 4.5X95MM.| SCREW LOCK 5X80.| SCREW LOCK 5X80MM.| SCREW LOCK 5X85MM.| SCREW NLCK 3.5X28MM.