BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LCC - PEEK 5 DEGREES MEDIUM SPACER - 10MM X 20MM X 8MM

    MDR report key: 4510613 · Received February 12, 2015

    Report

    Report Number
    2027467-2015-00002
    Event Type
    Malfunction
    Date Received
    February 12, 2015
    Date of Event
    January 14, 2015
    Report Date
    January 19, 2015
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    MQP
    PMA / PMN Number
    K042201
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION FOUND THAT THE CAGE HAD FRACTURED/CRACKED AT THE ID THREADS WHERE THE INSERTER ATTACHES/MATES. THE FAILURE MODE INDICATES THAT THE INSERTER MAY HAVE NOT BEEN FULLY THREADED UPON STRIKING AND/OR THE POSSIBILITY OF INADEQUATE DISK HEIGHT NECESSARY TO ALLOW INSERTION OF THE IMPLANT DUE TO NOT TRIALING THE DISC SPACE PRIOR TO IMPLANTATION. BOTH PLACE EXCESSIVE LOAD ON THE DEVICE AND INTRODUCE STRESS/FORCES IT WAS NOT DESIGNED TO WITHSTAND. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ANOMALIES. THE RETURNED PEEK CAGE WAS PROPERLY MANUFACTURED AND RELEASED ACCORDING TO DESIGN SPECIFICATIONS. THE NOVEL SPINAL SPACER SYSTEM IS AN INTERVERTEBRAL BODY FUSION DEVICE THAT CAN ALSO BE USED AS A VERTEBRAL REPLACEMENT DEVICE. THE IMPLANTS ARE A SPINAL FIXATION SYSTEM CONSISTING OF VARIOUS CYLINDRICAL SHAPES (FOOTPRINTS) OF VARYING LENGTHS, WIDTHS AND HEIGHTS TO ACCOMMODATE INDIVIDUAL PATIENT PATHOLOGY. SYSTEM IMPLANTS ARE MANUFACTURED OF SURGICAL GRADE TITANIUM ALLOY (ASTM F-136) OR POLYETHERETHERKEYTONE, PEEK (ASTM F-2026). A RADIOGRAPHIC MARKER MADE OF TITANIUM (ASTM F-136) OR TANTALUM (ASTM F-560) FACILITATES VISUALIZATION. THE NOVEL SPINAL SYSTEM MUST BE USED WITH A SUPPLEMENTAL SPINAL FIXATION SYSTEM. SPECIFICALLY, THE NOVEL SPINAL SPACER SYSTEM SHOULD BE USED WITH THE ALPHATEC ZODIAC® POLYAXIAL SYSTEM. THE NOVEL SPINAL SPACER SYSTEM AS A CERVICAL INTERVERTEBRAL BODY FUSION DEVICE SHOULD BE USED WITH THE ALPHATEC TRESTLE® SPINAL SYSTEM. WHEN USED AS AN INTERVERTEBRAL BODY FUSION, THE NOVEL SPINAL SPACER SYSTEM IS TO BE USED WITH AUTOGENOUS BONE GRAFT AND THESE PATIENTS SHOULD HAVE HAD SIX MONTHS OF NON-OPERATIVE TREATMENT.

    Description of Event or Problem · 1

    AN INTERNATIONAL CUSTOMER ((B)(6)) REPORTED THAT WHILE PERFORMING A PLIF CASE ON (B)(6) 2015, AN LLC PEEK CAGE FRACTURED AND BROKE. THE CAGE WAS ABOUT HALF WAY INTO THE L4/L5 DISK SPACE, THE SURGEON CONTINUED TO TAP ON IT TO GAIN FULL INSERTION WHEN THE IMPLANT BROKE. THE SURGEON WAS ABLE TO REMOVE 2 LARGE SECTIONS BUT REALIZED THE ENTIRE CAGE COULD NOT BE ACCOUNTED FOR. THE SURGEON SEARCHED THE SURGICAL SITE AND COULD NOT LOCATE THE REMAINDER OF THE PEEK CAGE. AFTER DETERMINING THIS WAS NOT A CRITICAL ISSUE, HE INSERTED A NEW LLC CAGE AND COMPLETED THE SURGERY WITHOUT FURTHER ISSUE. NO HEALTH INJURY OF THE PATIENT WAS CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106032 LCC - PEEK 5 DEGREES MEDIUM SPACER - 10MM X 20MM X 8MM MQP MQP ALPHATEC SPINE INC 64113-108 672678

    Patients

    Seq Age Sex Outcome Treatment
    1 Other