BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSTEOSYNTHESIS COMPRESSION STAPLE EASYCLIP 10X10X10MM

    MDR report key: 4202060 · Received October 27, 2014

    Report

    Report Number
    0008031020-2014-00497
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 29, 2014
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    JDR
    PMA / PMN Number
    K070031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED EVENT THAT EASYCLIP STAPLE HAD A BACK OUT AFTER SURGERY COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. AS WE HAVE NO INFORMATION REGARDING THE CIRCUMSTANCES OF THE BACK OUT WE CANNOT DETERMINE THE EXACT ROOT CAUSE OF THIS BREAKAGE. WE HAVE NO INFORMATION REGARDING PATIENT HEIGHT, WEIGHT AND WE DON¿T KNOW IF PATIENT RESPECTED POSTOPERATIVE CARE OR IF PATIENT KEPT AN IMPORTANT ACTIVITY WITHIN 6 WEEKS AFTER SURGERY. THEREFORE WE CANNOT EXCLUDE AN OVERLOAD, A FALL OR A TRAUMA. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. INDICATIONS FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE NOT DETERMINED IN THE INVESTIGATION. PLEASE NOTE THAT MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED. ADDITIONAL INFORMATION WAS REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    PATIENT HAD TWO EZCLIPS IMPLANTED ON (B)(6) 2014 AND HAD BOTH REMOVED ON (B)(6) 2014 DUE TO PAIN AND LOOSENING.

    Description of Event or Problem · 1

    PATIENT HAD TWO EZCLIPS IMPLANTED ON (B)(6) 2014 AND HAD BOTH REMOVED ON (B)(6) 2014 DUE TO PAIN AND LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683499 OSTEOSYNTHESIS COMPRESSION STAPLE EASYCLIP 10X10X10MM SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION APPLIANCES AND ACCESSORIES. JDR STRYKER TRAUMA SELZACH F004569PCBA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR