BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 6652898 · Received June 20, 2017

    Report

    Report Number
    2520274-2017-11825
    Event Type
    Injury
    Date Received
    June 20, 2017
    Date of Event
    September 15, 2015
    Report Date
    May 25, 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 USED FOR TREATMENT, NOT DIAGNOSIS. NO PATIENT INFORMATION REPORTED. LITERATURE CITATION: BACKES, MANOUK AND ET ALL. "PREDICTING LOSS OF HEIGHT IN SURGICALLY TREATED DISPLACED INTRA-ARTICULAR FRACTURES OF THE CALCANEUS" INTERNATIONAL ORTHOPAEDICS (SICOT) (2016) 40:513-518. THIS REPORT IS FOR UNKNOWN NON-LOCKING STAINLESS STEEL CALCANEAL PLATE CONSTRUCT WITH 3.5 MM STAINLESS STEEL SCREWS. PART UNKNOWN; UDI UNAVAILABLE. IMPLANT/EXPLANT DATES UNKNOWN. DEVICE IS UNAVAILABLE FOR RETURN. PART # IS UNKNOWN, 510K IS UNKNOWN. (B)(4). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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, BACKES, MANOUK AND ET ALL. "PREDICTING LOSS OF HEIGHT IN SURGICALLY TREATED DISPLACED INTRA-ARTICULAR FRACTURES OF THE CALCANEUS" INTERNATIONAL ORTHOPAEDICS (SICOT) (2016) 40:513-518 NETHERLANDS ARTICLE. A TOTAL OF 262 PATIENTS WITH 276 CALCANEAL FRACTURES OVER A 14-YEAR STUDY PERIOD FROM 2000-2014 WERE ASSESSED FOR POST OPERATIVE OUTCOMES FOR AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF CALCANEAL REPAIR SURGERY. PRIMARY COMPLICATION WAS THE OCCURRENCE OF A CALCANEAL COLLAPSE, DEFINED AS A POSTOPERATIVE DECREASE OF - 10 DEGREES. THE COLLAPSE OCCURRED IN 46 CASES; A 17% RATE. IT WAS NOTED THE COLLAPSE WAS ASSOCIATED WITH SUBSTANCE ABUSE AND POST-OPERATIVE WOUND INFECTION (POWI). THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR UNKNOWN NON-LOCKING STAINLESS STEEL CALCANEAL PLATE CONSTRUCT WITH 3.5 MM STAINLESS STEEL SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434537 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention