BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 7 HOLES/81MM

    MDR report key: 3140352 · Received May 31, 2013

    Report

    Report Number
    2520274-2013-03030
    Event Type
    Injury
    Date Received
    May 31, 2013
    Report Date
    May 7, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    K011335
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. MEDICAL RECORD # (B)(4). SHOULD BE X-RAYS INSTEAD OF TESTS.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. DATE OF X-RAYS SHOULD BE: (B)(6) 2011 INSTEAD OF (B)(6) 2011.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT UNDERWENT SURGERY FOR THE FIXATION OF A RIGHT FIBULA NON-UNION. PRIOR TO IMPLANTING A 7-HOLE PLATE, A 3.5MM CORTEX SCREW AND FIVE, 3.5MM LOCKING SCREWS, THE NON-UNION SITE WAS DEBRIDED AND REDUCED. AFTER IMPLANTING THE DEVICES, THE FRACTURE WAS VISUALIZED AND REDUCTION AND OVERALL PLATE PLACEMENT WERE VERIFIED. IT WAS ALSO DOCUMENTED THAT THE FRACTURE SITE HAD GOOD APPOSITION. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN SATISFACTORY CONDITION. ON (B)(6) 2011, IT WAS NOTED THAT THE PLATE WAS BROKEN RESULTING IN A REVISION SURGERY WHICH WAS PERFORMED ON (B)(6) 2011. IT WAS REPORTED THAT AS OF (B)(6) 2012, THE FRACTURE WAS HEALED. THIS REPORT IS #1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    FOLLOWING THE (B)(6) 2011 SURGERY, PATIENT CONTINUED TO EXPERIENCE PROBLEMS INCLUDING PAIN AND SWELLING OF THE RIGHT ANKLE AND LEG. THERE WAS A LOSS OF FIXATION AND THE PLATE WAS NOTED AS BROKEN. PATIENT CONTINUED TO RECEIVE FOLLOW UP CARE FROM SURGEON FROM THE (B)(6) 2011 SURGERY AND REMAINED IN A FRACTURE BOOT FOR SEVERAL WEEKS AS THE FIBULA FRACTURED HEALED. THIS IS REPORT 1 OF 1 FOR COMPLAINT # (B)(4).

    Description of Event or Problem · 1

    WHEN PATIENT UNDERWENT REVISION SURGERY FOR A SYMPTOMATIC FIBULAR NONUNION AND BROKEN PLATE, THE BROKEN PLATE WAS REMOVED AND A NEW PLATE WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242267 LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 7 HOLES/81MM HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention