BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_FRO_PRODUCT

    MDR report key: 3771397 · Received April 24, 2014

    Report

    Report Number
    0008010177-2014-00108
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 2, 2014
    Manufacturer
    STRYKER LEIBINGER FREIBURG (MDR)
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE EVALUATION REVEALED THE BROKEN PLATE AND BROKEN SCREW TO BE PRIMARY PRODUCTS. AN INVESTIGATION OF THE IMPLANTS THEMSELVES WAS NOT POSSIBLE BECAUSE BOTH IMPLANTS WERE NOT AVAILABLE. A REVIEW OF THE MANUFACTURING AND INSPECTION DOCUMENTS (DHR) WAS POSSIBLE FOR THE PLATE; NO DISCREPANCIES WERE DETECTED. A DHR REVIEW WAS NOT POSSIBLE FIR THE SCREW BECAUSE THE LOT CODE WAS NOT PROVIDED. THE REPORTED PLATE AND SCREW BREAKAGES WERE CONFIRMED VIA X-RAYS; THE PLATE BROKE APPROX. IN HALF; THE BROKEN SCREW WAS IMPLANTED THROUGH THE FIBULA INTO THE TIBIA BONE. THE CUSTOMER REPORTED THAT A NONUNION WAS DETECTED. NON-UNIONS ARE IFU-LISTED ADVERSE EFFECTS THAT CAN LEAD TO IMPLANT FAILURES LIKE BREAKAGES. IF OTHER LISTED ADVERSE EFFECTS (I.E. OBESITY, POOR BONE QUALITY, IMPLANT DAMAGES) DID CAUSE OR CONTRIBUTE TO THE IMPLANT BREAKAGES COULD NOT BE DETERMINED DUE TO MISSING INFORMATION. BECAUSE NO MANUFACTURER FAULT WAS DETECTED A PRODUCT RELATED ISSUE CAN BE EXCLUDED. NO NONCONFORMITY IDENTIFIED.

    Description of Event or Problem · 1

    THE PLATE AND SCREW BROKE. PATIENT WAS A NONUNION. SURGEON WAS DISSATISFIED WITH THE PLATE AND THOUGHT THE LOCKING MECHANISM SHOULD BE STRONGER. NOT ALL BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. NEW PLATE AND SCREWS PLACED.

    Description of Event or Problem · 1

    THE PLATE AND SCREW BROKE. PATIENT WAS A NONUNION. SURGEON WAS DISSATISFIED WITH THE PLATE AND THOUGHT THE LOCKING MECHANISM SHOULD BE STRONGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249170 UNKNOWN_FRO_PRODUCT IMPLANT HRS STRYKER LEIBINGER FREIBURG (MDR) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention