BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOFFMAN CONNECTING ROD

    MDR report key: 1620526 · Received February 5, 2010

    Report

    Report Number
    8031020-2009-00146
    Event Type
    Injury
    Date Received
    February 5, 2010
    Date of Event
    January 11, 2007
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH, STRYKER OSTEOSYNTHESIS
    Product Code
    JEC
    PMA / PMN Number
    K961916
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF A QUALITY SYSTEM IMPROVEMENT PLAN, STRYKER CORPORATION CONDUCTED A 2 YEAR RETROSPECTIVE MDR REVIEW TO ENSURE APPROPRIATE MDR REPORTING DECISIONS. EVENTS REPORTED TO STRYKER FROM (B) (6) 2006 TO (B) (6) 2008 WERE THE SCOPE OF THIS RETROSPECTIVE REVIEW. THESE EVENTS ARE PART OF A RETROSPECTIVE SUMMARY REPORT BEING SUBMITTED UNDER EXEMPTION (B) (4).

    Description of Event or Problem · 1

    DEVICE BROKE OR DISASSEMBLED DURING USE. "IT WAS REPORTED THAT "SURGEON STATED THAT THE HOFFMAN II COMPACT FRAME HAD (1) BROKEN ROD. PT CLAIMED THAT SHE HAS NOT WALKED ON IT OR HAD HIT THE FRAME ON ANYTHING. FROM OUR OBSERVATION, THE PT HAD BENT (1) APEX PIN. WE ALSO OBSERVED 2 BROKEN CARBON RODS. THE INTEGRITY OF THE APEX PIN WAS NOT COMPROMISED. HOWEVER, IT WAS NECESSARY TO REPLACE (2) CARBON FIBER RODS ON THE FRAME".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOFFMAN CONNECTING ROD IMPLANT JEC STRYKER OSTEOSYNTHESIS SELZACH, STRYKER OSTEOSYNTHESIS NA M06283

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other