BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 6646870 · Received June 16, 2017

    Report

    Report Number
    2520274-2017-11816
    Event Type
    Injury
    Date Received
    June 16, 2017
    Report Date
    May 24, 2017
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS. JIN, C ET AL (2017) MINIMALLY INVASIVE PERCUTANEOUS OSTEOSYNTHESIS VERSUS ORIF FOR SANDERS TYPE II AND III CALCANEAL FRACTURES: A PROSPECTIVE, RANDOMIZED INTERVENTION TRIAL. JOURNAL OF ORTHOPAEDIC SURGERY AND RESEARCH 12:10, PP: 1-9. THIS REPORT IS FOR AN UNKNOWN CALCANEUS PLATE. (OTHER NUMBER) UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICES WERE RETURNED AND NO LOT NUMBERS OR PART NUMBERS WERE PROVIDED. (B)(4). 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 JOURNAL ARTICLE: JIN, C ET AL (2017) MINIMALLY INVASIVE PERCUTANEOUS OSTEOSYNTHESIS VERSUS ORIF FOR SANDERS TYPE II AND III CALCANEAL FRACTURES: A PROSPECTIVE, RANDOMIZED INTERVENTION TRIAL. JOURNAL OF ORTHOPAEDIC SURGERY AND RESEARCH 12:10, PP: 1-9. THE PURPOSE OF THIS STUDY WAS TO DESCRIBE THE MINIMALLY INVASIVE PERCUTANEOUS OSTEOSYNTHESIS (MIPO) TECHNIQUE AND TO EVALUATE THE CLINICAL OUTCOMES AND COMPLICATIONS OF THIS TECHNIQUE COMPARED WITH CONVENTIONAL TREATMENT FOR SANDERS TYPE II AND III CALCANEAL FRACTURES USING AN EXTENDED L-SHAPED LATERAL APPROACH. FROM MAY 2011 TO NOVEMBER 2013, 64 CONSECUTIVE PATIENTS WITH UNILATERAL CALCANEAL FRACTURES THAT MET THESE CRITERIA WERE INCLUDED IN THE STUDY. PATIENTS WERE ALLOCATED IN ACCORDANCE WITH THE RANDOM NUMBER TABLE AND DIVIDED INTO TWO GROUPS, A MIPO GROUP AND AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) CONVENTIONAL GROUP. A CALCANEUS PLATE AND SCREWS (AO SYNTHES, (B)(4)) WAS USED FOR INTERNAL FIXATION IN BOTH GROUPS. DEEP INFECTION OCCURRED IN 2 OF THE 35 (5.7%) PATIENTS IN THE CONVENTIONAL TREATMENT GROUP. THESE TWO PATIENTS WITH DEEP INFECTIONS WERE TREATED WITH DEBRIDEMENT TWICE AS WELL AS WITH INTRAVENOUS ANTIBIOTICS, WITHOUT SUCCESS. FINALLY, IMPLANT REMOVAL WAS EXECUTED. THIS REPORT IS FOR AN UNKNOWN CALCANEUS PLATE. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427418 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention