BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALAXO SCREW

    MDR report key: 1953145 · Received January 7, 2011

    Report

    Report Number
    1219602-2011-00008
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Report Date
    December 9, 2010
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURE
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SMITH & NEPHEW, INC. ENDOSCOPY DIV IS SUBMITTING THE ENCLOSED REPORT TO COMPLY WITH 21 CFR 803, THE MDR REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY SMITH & NEPHEW INC. ENDOSCOPY DIV WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE OF THE REPORT WAS REQUIRED BY FDA. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT EXPERIENCED POST-OP CONDITION WITH PERSISTENT KNEE PAIN. (B)(6) 2007 ACHILLES ALLOGRAFT RECONSTRUCTION REVISION, ACL RECONTRUCTION, SCREW REMOVAL FROM LEFT KNEE. (B)(6) 2008, MRI IMPRESSION: STATUS POST ACL REPAIR. GRAFT APPEARS INTACT AND IN PLACE. LATERAL MENISCAL TEAR AND PARTIAL MENISCECTOMY. (B)(6) 2010, PERSISTENT LEFT KNEE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CALAXO SCREW CALAXO SCREW,7MM X 25MM,STERILE BOX OF 1 HWC SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURE 7211113 50215169

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR