BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSTEORAPTOR

    MDR report key: 3325549 · Received September 4, 2013

    Report

    Report Number
    1219602-2013-00201
    Event Type
    Injury
    Date Received
    September 4, 2013
    Report Date
    August 9, 2013
    Manufacturer
    SMITH & NEPHEW MANSFIELD MANUFACTURING SITE
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ON AUGUST 6, 2013, SMITH & NEPHEW ISSUED A VOLUNTARY RECALL. (B)(4).

    Description of Event or Problem · 1

    FOLLOWING A SURGICAL PROCEDURE WHEREIN AN UNKNOWN OSTEORAPTOR 2.3 SUTURE ANCHOR WAS REPORTEDLY USED THE PATIENT DEVELOPED A SUPERFICIAL INFECTION. A SMITH & NEPHEW MEDICAL ADVISOR FOLLOWED UP DIRECTLY WITH THE OPERATING SURGEON WHO INDICATED THAT HE DID HAVE A PATIENT EXPERIENCE A POST-OPERATIVE INFECTION; HOWEVER AN ANCHOR WAS NOT INSERTED INTO THAT PATIENT. THE SURGEON SPECIFICALLY INDICATED THAT THE ISSUE WAS NOT ANCHOR RELATED, HOWEVER, THIS CANNOT BE CONFIRMED. THE PATIENT WAS REPORTED AS HEALING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437353 OSTEORAPTOR UNKNOWN OSTEORAPTOR 2.3 SUTURE ANCHOR HWC SMITH & NEPHEW MANSFIELD MANUFACTURING SITE

    Patients

    Seq Age Sex Outcome Treatment
    1