BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 5403647 · Received February 2, 2016

    Report

    Report Number
    2520274-2016-10623
    Event Type
    Injury
    Date Received
    February 2, 2016
    Date of Event
    June 16, 2007
    Report Date
    January 14, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR UNKNOWN METAPHYSEAL LOCKING PLATE (MIPO)/UNKNOWN QUANTITY/UNKNOWN LOT. (B)(4). 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. 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

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE LAU, T; LEUNG, F; CHAN, C AND CHOW, S. (2008). WOUND COMPLICATION OF MINIMALLY INVASIVE PLATE OSTEOSYNTHESIS IN THE DISTAL TIBIA FRACTURES. INTERNATIONAL ORTHOPAEDICS (SICOT),32: 697-703. THIS RETROSPECTIVE STUDY WAS PERFORMED TO IDENTIFY THE CLINICAL OUTCOME WITH SPECIAL ATTENTION TO THE RATE OF INFECTION AS WELL AS ITS EFFECT ON THE FRACTURE HEALING USING METAPHYSEAL LOCKING PLATE BY THE (MIPO) TECHNIQUE IN FRACTURE OF THE DISTAL TIBIA. FROM MARCH 2003 TO AUGUST 2006, 48 DISTAL TIBIA FRACTURE FIXATIONS USING LOCKING PLATE BY THE (MIPO) TECHNIQUE WERE PERFORMED. THERE WERE 24 MALE AND 24 FEMALE PATIENTS. THE AGES RANGED FROM 21 TO 87 YEARS WITH AN AVERAGE OF 51 YEARS. ALL PATIENTS FOLLOWED-UP WITHIN 6 MONTHS. THE LONGEST FOLLOW-UP WAS 45 MONTHS WITH AN AVERAGE FOLLOW-UP PERIOD OF 18.7 MONTHS. THE AVERAGE TIME TO RADIOLOGICAL BONY UNION WAS 18.7 WEEKS, WHICH RANGED FROM THE SHORTEST 12 WEEKS TO THE LONGEST 44 WEEKS. THIS REPORT IS FOR UNKNOWN METAPHYSEAL LOCKING PLATE (MIPO). THIS IS REPORT 1 OF 9 FOR (B)(4) AND REFERS TO CASE 6, ((B)(6) FEMALE): WHO REQUIRED BONE GRAFT IN 12 WEEKS AFTER FIRST OSTEOSYNTHESIS TO ACHIEVE BONY UNION AND ALSO PATIENT HAD POST-OPERATIVE IMPLANT IMPINGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62982 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention