BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALAMO T INTERVENTEBRAL BODY FUSION DEVICE

    MDR report key: 4756313 · Received May 6, 2015

    Report

    Report Number
    3008520015-2015-00003
    Event Type
    Malfunction
    Date Received
    May 6, 2015
    Date of Event
    April 6, 2015
    Report Date
    May 5, 2015
    Manufacturer
    ALLIANCE PARTNERS LLC (DBA ALLIANCE SPINE)
    Product Code
    KWQ
    PMA / PMN Number
    K140303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2014, THE ALAMO T INTERVERTEBRAL BODY FUSION DEVICE, PART #2811I-010 LOT #SM 56676 (CLASS II DEVICE), WAS RECEIVED FROM THE CONTRACTED MANUFACTURER. THE CAGE IS CONSTRUCTED OF PEEK OPTIMA ACCORDING TO SPECIFICATION. CERTIFICATE OF CONFORMANCE FOR MATERIAL AND TESTING ARE ON FILE. THE LOT WAS INSPECTED TO AN AQL 1 GENERAL LEVEL 2 AND CONSISTED OF (B)(4), WHICH REQUIRED AN INSPECTION OF 20 ACCORDING TO ANSI/ASQC ZL.4-1993. THE LOT WAS INSPECTED WITH NO NON-CONFORMANCES AND RELEASED TO INVENTORY. ON (B)(6) 2015, THE ALAMO T INTERVERTEBRAL BODY FUSION DEVICE, PART #2811I-010 LOT # SM56676 WAS RETURNED BACK TO THE MAIN OFFICE FOR EVALUATION. ON 05/04/2015, THE ENGINEERING DEPT. COMPLETED THE EVALUATION ON THE RETURNED BROKEN ALAMO T CAGE. THERE WAS NO DAMAGE AT THE INTERFACE BETWEEN THE BROKEN ALAMO T CAGE AND THE INSERTER INSTRUMENT. THE ENGINEERING TEAM ATTEMPTED TO RECREATE THE FAILURE USING SAWBONES AND AN IDENTICAL ALAMO T CAGE PART # 2811I-010 FROM THE SAME LOT # SM56676. IMAGES FROM THE ATTEMPTED RECREATION OF FAILURE ARE LOCATED IN THE FILE ATTACHMENTS. THE IMPLANT DID NOT HAVE ANY DAMAGE PRIOR TO OR AFTER ATTEMPTED RECREATION. BASED ON THE EVALUATION, THE ENGINEERING DEPARTMENT CONCLUDED EXCESSIVE FORCE WAS USED DURING INSERTION OF THE IMPLANT RESULTING IN IMPLANT FAILURE. ONE COMPLAINT WAS REPORTED LAST YEAR, RELATED TO A BROKEN CAGE BY EXCESSIVE FORCE. THE ALLIANCE SPINE QUALITY DEPT WILL CONTINUE TO MONITOR.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE ALAMO T CAGE, PART #2811I-010 LOT #SM56676 WAS REPORTED BROKEN DURING A SURGERY AT THE HOSPITAL. THE SURGEON WAS PREPPING THE DISC SPACE FOR AN L5-S1 INSERTION. THE SCRUB TECH PRESENT LOADED THE 10MM ALAMO T CAGE PART #2811T-010 LOT # SM56676 AND HANDED IT TO THE DOCTOR. THE DOCTOR THEN POSITIONED THE LOADED INSERTER BETWEEN L5-S1 DISC SPACE. THE SURGEON STRUCK THE ALAMO T CAGE WITH A MALLET AND ON THE FOURTH HIT THE CAGE BROKE. ACCORDING TO THE ALLIANCE SPINE FIELD REP THE HITS WERE NOT HARD. THERE WERE NO REPORTED INJURIES TO THE PT AND THE BROKEN CAGE WAS SENT BACK TO THE OFFICE FOR FURTHER EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298150 ALAMO T INTERVENTEBRAL BODY FUSION DEVICE INTERVERTEBRAL BODY FUSION DEVICE KWQ ALLIANCE PARTNERS LLC (DBA ALLIANCE SPINE) 2811I-010 SM56676

    Patients

    Seq Age Sex Outcome Treatment
    1 Other