BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - PLATES: SPINE

    MDR report key: 11404932 · Received March 3, 2021

    Report

    Report Number
    8030965-2021-01547
    Event Type
    Injury
    Date Received
    March 3, 2021
    Report Date
    February 9, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). THIS REPORT IS FOR ONE (1) UNKNOWN PLATE- SPINE/PART AND LOT NUMBERS ARE UNKNOWN. WITHOUT THE SPECIFIC PART AND LOT NUMBER, THE UDI IS NOT AVAILABLE. COMPLAINANT DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. INJURY. INVESTIGATION SUMMARY: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN CHINA AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: ZHANG S.H., ET AL (2012)CLINICAL APPLICATION OF TITANIUM MINIPLATE IN CERVICAL EXPANSIVE OPEN DOOR LAMINOPLASTY, CHINA JOURNAL OF ORTHOPEDICS AND TRAUMATOLOGY VOLUME 25(1), PAGES 4- 8 (CHINA). THIS STUDY AIMS TO EVALUATE CLINICAL APPLICATION OF TITANIUM MINIPLATE IN CERVICAL EXPANSIVE OPEN DOOR LAMINOPLASTY. BETWEEN FEBRUARY 2009 AND APRIL 2011, A TOTAL OF 20 CSM PATIENTS ARE TREATED WITH EXPANSIVE LAMINOPLASTY COMBINED WITH ARCH TITANIUM INTERNAL FIXATION (GROUP A). AMONG THEM, 16 PATIENTS ARE FOLLOWED UP (12 MALES AND 4 FEMALES) AGE FROM 45 TO 69 YEARS OLD, WITH AN AVERAGE OF (58.3±13.5). BETWEEN MARCH 2007 AND JANUARY 2009, 25 CSM PATIENTS ARE TREATED WITH EXPANSIVE LAMINOPLASTY (GROUP B)THE THREAD SUTURE FIXATION. 18 PATIENTS ARE FOLLOWED UP, (13 MALES AND 5 FEMALES) AGE FROM 43 TO 67 YEARS OLD, WITH AN AVERAGE OF (56.5±14.5), THE THREAD SUTURE FIXATION WAS USED. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: GROUP A: 1 IS SATISFACTORY AND 2 ARE POOR RESULT ACCORDING TO AS SYMPTOM. SIGNIFICANT POST-OPERATIVE AS SYMPTOM IS OBSERVED IN 3 PATIENTS. COMPARED TO THE PRE-OPERATIVE DATA, LORDOSIS INCREASE OCCURS IN 8 PATIENTS FROM GROUP A WHEN THEY ARE FOLLOWED UP 6 MONTHS POST OPERATION, NO CHANGE FOR 2 PATIENTS AND DECREASE FOR 6 PATIENTS. THIS REPORT IS FOR AN UNKNOWN SYNTHES ARCH TITANIUM MINIPLATE BY AO. THIS REPORT IS FOR ONE (1) UNK - PLATES: SPINE. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304301 UNK - PLATES: SPINE PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention