BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALAMO T INTERVERTEBRAL BODY FUSION DEVICE

    MDR report key: 6058276 · Received October 26, 2016

    Report

    Report Number
    3008520015-2016-00004
    Event Type
    Malfunction
    Date Received
    October 26, 2016
    Date of Event
    September 19, 2016
    Report Date
    October 19, 2016
    Manufacturer
    ALLIANCE PARTNERS LLC (DBA ALLIANCE SPINE)
    Product Code
    MAX
    PMA / PMN Number
    K140303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALAMO T IMPLANT (PART # 2811T-1008, LOT #SM56678), WAS RECEIVED FROM THE CONTRACTED MANUFACTURER AS PART OF A LOT QUANTITY OF (B)(4) ON 4/25/2014. THE LOT WAS INSPECTED TO ANSI/ASQ Z1.4-1993 GENERAL LEVEL II 1.0 AQL SAMPLING PLAN AND RELEASED INTO INVENTORY. ENGINEERING EVALUATION WAS COMPLETED ON 10/13/2016. EVALUATION INCLUDED VISUAL INSPECTION OF THE RETURNED ALAMO T INTERBODY CAGE TO DETERMINE WHERE PRIMARY FRACTURE OCCURRED. RESULTS WERE AS FOLLOWS: PRIMARY FRACTURES OCCURRED ON THE MEDIAL WALL WITH WINDOW FEATURES; AND A SECONDARY FRACTURE OCCURRED ON THE OPPOSING MEDIAL WALL AS A RESULT OF THE LOCALIZED STRESSES GENERATED BY THE PRIMARY FRACTURES. WHEN OVER-IMPACTED, INTERBODY CAGES ARE DESIGNED TO FRACTURE ON THE WALLS. AS A RESULT, BASED ON THE OBSERVED LOCATIONS OF FRACTURE, EVALUATION CONCLUDED THAT THE INTERBODY CAGE WAS IMPACTED WITH EXCESSIVE FORCE, CAUSING THE DEVICE TO FAIL AS DESIGNED.

    Description of Event or Problem · 1

    ON (B)(6) 2016, AT (B)(6), DURING IMPLANTATION OF AN 8MM ALAMO T INTERBODY CAGE (PART NUMBER 2811I-008; LOT NUMBER SM56678) IN A LUMBAR FUSION PROCEDURE, THE CAGE BROKE. THE BROKEN ALAMO T CAGE, INCLUDING ALL MATERIAL FRAGMENTS/PIECES, WERE CAREFULLY REMOVED FROM THE PATIENT AND ANOTHER ALAMO T CAGE WAS IMPLANTED. THE BROKEN CAGE WAS SENT BACK TO ALLIANCE SPINE FOR EVALUATION. NO INJURIES WERE REPORTED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709803 ALAMO T INTERVERTEBRAL BODY FUSION DEVICE INTERVERTEBRAL BODY FUSION DEVICE MAX ALLIANCE PARTNERS LLC (DBA ALLIANCE SPINE) 2811I-008 SM56678

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR