BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZODIAC POLYAXIAL SCREW SYSTEM

    MDR report key: 926804 · Received October 9, 2007

    Report

    Report Number
    2027467-2007-00012
    Event Type
    Other
    Date Received
    October 9, 2007
    Report Date
    October 9, 2007
    Manufacturer
    ALPHATEC SPINE, INC.
    Product Code
    MNH
    PMA / PMN Number
    K033090
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF IMPLANT SURGERY AIDED IN DETERMINING THE CORRECT PART AND LOT NUMBER OF THE ROD (ALLEGED DEVICE) USED FOR THE INITIAL IMPLANT SURGERY. THE DEVICE HISTORY RECORD OF PART INVOLVED WAS REVIEWED. THE EVALUATION OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY QUALITY CONCERNS. THE INITIAL REPORTER WAS CONTACTED ON 09/11/2007 AT 9:00AM BY PHONE, EXPLAINED THE INCIDENT IN MORE DETAIL AND INDICATED THAT HE WOULD BE RETURNING THE RETRIEVED DEVICE BACK TO THE MANUFACTURER. REGULATORY AFFAIRS HAS MADE SEVERAL ATTEMPTS TO OBTAIN THE DEVICE, WITH NO RESPONSE. THE PARTS REMOVED FROM THE PATIENT WERE NOT RETURNED TO THE MANUFACTURER. THE PARTS WERE NOT AVAILABLE FOR EVALUATION. CONTINUED FROM SECTION A7. THE PACKAGE INSERT STATES: ADVERSE EFFECTS: THE FOLLOWING COMPLICATIONS AND ADVERSE REACTIONS HAVE BEEN SHOWN TO OCCUR WITH THE USE OF SIMILAR SPINAL INSTRUMENTATION. THESE EFFECTS AND ANY OTHER KNOWN BY THE SURGEON MUST BE DISCUSSED WITH THE PATIENT PREOPERATIVELY. NON-UNION AND/OR PSEUDOARTHROSIS. REVISION SURGERY. POSTOPERATIVE MANAGEMENT: POSTOPERATIVE MANAGEMENT BY THE SURGEON, INCLUDING INSTRUCTION AND WARNING AND COMPLIANCE BY THE PATIENT OF THE FOLLOWING IS ESSENTIAL: SURGEON SHOULD INSTRUCT THE PATIENT REGARDING AMOUNT AND TIME FRAME AFTER SURGERY OF ANY WEIGHT BEARING ACTIVITY. THE INCREASED RISK OF BENDING... IMPLANT DEVICES SHOULD BE REVISED OR REMOVED IMMEDIATELY IF APPROPRIATE UPON A CASE OF NON-UNION, PSEUDOARTHROSIS OR IF THE DEVICE HAS BEEN BENT, DISLOCATED OR BROKEN. THE ZODIAC SPINAL FIXATION SYSTEM IMPLANTS ARE DESIGNED AND INTENDED AS TEMPORARY FIXATION DEVICES. DUE TO THE PART NOT RETURNED AND THE CIRCUMSTANCES SURROUNDING THE EVENT A ROOT CAUSE CANNOT BE IDENTIFIED.

    Description of Event or Problem · 1

    THE PATIENT BENT OVER AND HEARD A SNAP AND POPPING SOUND. IMMEDIATELY AFTERWARDS, THE PATIENT EXPERIENCED PAIN. THE DATE OF THIS INCIDENT IS UNKNOWN. THE INITIAL REPORTER INDICATED THAT THE SURGEON SUSPECTED THAT THE ROD WAS AT FAULT BUT DID NOT MENTION THE RATIONALE BEHIND IT. PATIENT UNDERWENT A REVISION SURGERY TO CORRECT THE PROBLEM IN 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZODIAC POLYAXIAL SCREW SYSTEM ZODIAC PEDICLE SCREW SYSTEM MNH ALPHATEC SPINE, INC. 62002-30 26768A

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention