BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECONSTRUCTION NAIL R2.0, TI, LEFT T2 RECON 11X340 MM X 125

    MDR report key: 10583570 · Received September 24, 2020

    Report

    Report Number
    0009610622-2020-00544
    Event Type
    Injury
    Date Received
    September 24, 2020
    Date of Event
    August 10, 2020
    Report Date
    November 23, 2020
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    UDI-DI
    07613153316619
    PMA / PMN Number
    K032898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE NO OTHER EVIDENCE LIKE MEDICAL REPORTS WERE PROVIDED. A DEVICE INSPECTION WAS NOT POSSIBLE SINCE THE AFFECTED DEVICE WAS NOT RETURNED AND NO OTHER EVIDENCE WAS PROVIDED FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. NO INDICATIONS OF MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT, PATIENT RECORD AND MEDICAL REPORTS MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Description of Event or Problem · 0

    "A CT SCAN OF THE PELVIS SUBSEQUENTLY REVEALED AN INTRA-ARTICULAR COXO-FEMORAL SCREW ON THE RIGHT LEG. LAG SCREW WAS REVISED THE (B)(6) 2020." CLARIFICATION RECEIVED: "INSTALLED ON 19/07/2020 : T2 FEMUR CLOU RECON 11X320MM GH REFERENCE : 1846-1134S LOT : K037023. FOLLOWING AN INFECTION OF THE OSTEOSYNTHESIS MATERIAL LEFT LEG NAIL WITH STAPHYLOCOCCUS EPIDERMITIS AND ACINETOBACTER BAUMANNII, CHANGE OF THE MATERIAL. INSTALLED ON (B)(6) 2020 : T2 FEMUR CLOU RECON 11X320MM GH REFERENCE : (B)(4) LOT : K880065RA (CURRENTLY IMPLANTED)".

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    "A CT SCAN OF THE PELVIS SUBSEQUENTLY REVEALED AN INTRA-ARTICULAR COXO-FEMORAL SCREW ON THE RIGHT LEG. LAG SCREW WAS REVISED THE (B)(6) 2020." CLARIFICATION RECEIVED: "INSTALLED ON (B)(6) 2020 : T2 FEMUR CLOU RECON 11X320MM GH REFERENCE : 1846-1134S LOT : K037023. FOLLOWING AN INFECTION OF THE OSTEOSYNTHESIS MATERIAL LEFT LEG NAIL WITH STAPHYLOCOCCUS EPIDERMITIS AND ACINETOBACTER BAUMANNII, CHANGE OF THE MATERIAL. INSTALLED ON 20/08/2020 : T2 FEMUR CLOU RECON 11X320MM GH REFERENCE : 1846-1132S LOT : K880065RA (CURRENTLY IMPLANTED)"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1046512 RECONSTRUCTION NAIL R2.0, TI, LEFT T2 RECON 11X340 MM X 125 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL 1846-1134S K037023 07613153316619

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention