BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 6560069 · Received May 11, 2017

    Report

    Report Number
    2520274-2017-11629
    Event Type
    Injury
    Date Received
    May 11, 2017
    Report Date
    April 13, 2017
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PERISANO, C. ET AL (2016) INDICATIONS FOR PROPHYLACTIC OSTEOSYNTHESIS ASSOCIATED WITH CURETTAGE IN BENIGN AND LOW-GRADE MALIGNANT PRIMITIVE BONE TUMORS OF THE DISTAL FEMUR IN ADULT PATIENTS: A CASE SERIES. J ORTHOPAED TRAUMATOL (2016) 17:377¿382. THIS REPORT IS FOR UNKNOWN LOCKING COMPRESSION PLATE, UNKNOWN QUANTITY, UNKNOWN LOT. OTHER NUMBER: UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    LITERATURE ARTICLE RECEIVED. THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: PERISANO, C. ET AL (2016) INDICATIONS FOR PROPHYLACTIC OSTEOSYNTHESIS ASSOCIATED WITH CURETTAGE IN BENIGN AND LOW-GRADE MALIGNANT PRIMITIVE BONE TUMORS OF THE DISTAL FEMUR IN ADULT PATIENTS: A CASE SERIES. J ORTHOPAED TRAUMATOL (2016) 17:377¿382 TWELVE CASES OF BENIGN AND LOW-GRADE MALIGNANT BONE LESIONS OF THE DISTAL FEMUR IN ADULT PATIENTS TREATED IN AN ORTHOPEDIC DEPARTMENT BETWEEN 2008 AND 2011 WITH CURETTAGE, BONE FILLING AND PREVENTIVE OSTEOSYNTHESIS. THE PLATES USED WERE THE LESS INVASIVE STABILIZATION SYSTEM (LISS, SYNTHES) OR THE LOCKING COMPRESSION PLATE 4.5 (SYNTHES). PATIENTS WERE ENROLLED RETROSPECTIVELY AND A FINAL FOLLOWUP WAS PERFORMED. THE MEAN AGE OF PATIENTS (8 FEMALES AND 4 MALES) WAS 31.6 ± 9.6 YEARS (RANGE 18¿47 YEARS). THE HARDWARE WAS REMOVED IN ALL PATIENTS AFTER AT LEAST 1 YEAR AFTER SURGERY. THE 4.5 LCP PLATE, PATIENT 5, B)(6) FEMALE, EXPERIENCED PAIN DUE TO HARDWARE REQUIRING HARDWARE REMOVAL THIS IS REPORT 2 OF 2 FOR B)(4). THIS REPORT IS FOR AN UNKNOWN PLATE (LISS OR 4.5 LCP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343153 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention