BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3875492 · Received June 16, 2014

    Report

    Report Number
    2520274-2014-11707
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    November 27, 2013
    Report Date
    June 3, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR AN UNKNOWN SCREW. 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, M. ET AL. (2014). WOUND INFECTIONS FOLLOWING OPEN REDUCTION AND INTERNAL FIXATION OF CALCANEAL FRACTURES WITH AN EXTENDED LATERAL APPROACH. INTERNATIONAL ORTHOPAEDICS. (38), 767-773. POST-OPERATIVE WOUND INFECTIONS (PWI) FOLLOWING CALCANEAL FRACTURE SURGERY CAN LEAD TO PROLONGED HOSPITAL STAY AND ADDITIONAL TREATMENT WITH ANTIBIOTICS, SURGICAL DEBRIDEMENT OR IMPLANT REMOVAL. THE AIM OF THIS STUDY WAS DETERMINE INCIDENCE OF SUPERFICIAL AND DEEP PWI AND TO IDENTIFY RISK FACTORS. FROM 2000 TO 2010, THIS STUDY LOOKED AT PATIENTS WITH A CLOSED UNILATERAL CALCANEAL FRACTURE TREATED WITH OPEN REDUCTION AND INTERNAL FIXATION BY EXTENDED LATERAL APPROACH. A TOTAL OF 191 PATIENTS WERE INCLUDED OF WHICH 47 PATIENTS HAD A PWI, 21 AND 26 PATIENTS HAD SUPERFICIAL AND DEEP WOUND INFECTIONS RESPECTIVELY. THERE WERE 26 PATIENTS WITH DEEP WOUND INFECTIONS. IN 8 PATIENTS, INTRAVENOUS ANTIBIOTICS TREATMENT AND SURGICAL DEBRIDEMENT WAS NOT SUCCESSFUL AND THE IMPLANT HAD TO BE REMOVED BECAUSE OF AN ONGOING INFECTION. PLACEMENT OF A CLOSED SUCTION DRAIN AT THE END OF SURGERY WAS ASSOCIATED WITH LESS PWI. A COPY OF THIS JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS REPORT IS 2 OF 2 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352899 SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention