BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRESTLE

    MDR report key: 1032254 · Received April 18, 2008

    Report

    Report Number
    2027467-2008-00010
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    April 15, 2008
    Report Date
    April 16, 2008
    Manufacturer
    ALPHATEC SPINE, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K070681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALPHATEC SPINE, INC. HAS REQUESTED X-RAYS OF THE PATIENT. AN INTERNAL INVESTIGATION IS IN PROCESS. AN EVALUATION OF THE PARTS IS PENDING. THE OUTCOME OF THE INVESTIGATION WILL BE SENT TO THE AGENCY IN AN ADDENDUM.

    Description of Event or Problem · 1

    THE PATIENT CAME INTO THE PHYSICIANS OFFICE COMPLAINING OF PAIN AND UNABLE TO SWALLOW. PATIENT WAS HAVING DIFFICULTY BREATHING. X-RAYS WERE TAKEN AND IT WAS DISCOVERED A SCREW WAS BACKING OUT OF THE CERVICAL PLATE. AN IMMEDIATE SURGERY WAS SCHEDULED FOR THE FOLLOWING DAY. DURING SURGERY, IT WAS DISCOVERED THAT THE FIVE REMAINING SCREWS WERE NOT LOCKED INTO THE CERVICAL PLATE. ONCE THE PLATE WAS REMOVED, IT WAS DISCOVERED THAT C-6 WAS FRACTURED. THE IMPLANTS WERE REMOVED AND THE (B) (4) PRODUCT LINE WAS USED TO COMPLETE THE SURGERY. THE PART NUMBER AND LOT NUMBER OF THE ANTERIOR CERVICAL PLATE IS: PART #61002-030 LOT #49651 MFRD 10/08/2007. THE PART NUMBERS FOR THE SCREWS ARE: PART #61240-016; LOT #615213; MFRD. 11/28/2007; PART #61440-016; LOT #614396; MFRD. 09/22/2007; PART #61345-016; LOT # 614012; MFRD. 08/27/2007. THE INITIAL SURGERY WAS PERFORMED ON (B) (6) 2008. THE LOCKING MECHANISMS WERE ENGAGED ONTO THE SCREWS AT THE TIME OF THE IMPLANT SURGERY. THE PATIENT IS CURRENTLY RECOVERING AND IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRESTLE TRESTLE ANTERIOR CERVICAL PLATING SYS. KWQ ALPHATEC SPINE, INC. PART #61002-30 49651

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention