BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.0MM TI CANC EXPANSIONHEAD SCREW SELF-TAPPING 14MM

    MDR report key: 4180496 · Received October 17, 2014

    Report

    Report Number
    2520274-2014-14175
    Event Type
    Injury
    Date Received
    October 17, 2014
    Report Date
    September 19, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    KWQ
    PMA / PMN Number
    PK031276
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANT DATE: IMPLANT DATE REPORTED AS (B)(6) 2013. (B)(4). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON APPROXIMATELY (B)(6) 2013, A FEMALE HAD ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) SURGERY. ON (B)(6) 2014, THIS CURRENTLY (B)(6)-YEAR-OLD FEMALE, HAD REVISION SURGERY WHICH INCLUDED THE REMOVAL OF EXISTING INSTRUMENTATION (1 PLATE AND 4 SCREWS) AND TO EXTEND ACDF C4-C5 TO C5-C6 DUE TO PAIN WITH ADJACENT LEVEL DISC DISEASE. DURING THE REVISION SURGERY, THE SURGEON COULD NOT LOAD THE 5MM LORDOTIC TRIAL SPACER ONTO THE TRIAL INSERTER. UPON INSPECTION IT WAS FOUND THAT THE TIP OF THE TRIAL INSERTER WAS CROSS THREADED. ANOTHER TRIAL SPACER INSERTER WAS AVAILABLE TO USE. THERE WERE NO FRAGMENTS TO RETRIEVE. THE SURGERY WAS COMPLETED WITH NO EXTENSION OF TIME. PATIENT OUTCOME WAS CONSIDERED AS SUCCESSFUL. THIS IS REPORT NUMBER 3 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662849 4.0MM TI CANC EXPANSIONHEAD SCREW SELF-TAPPING 14MM APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY KWQ SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention