BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SD - PEEK SMALL SPACER - 9MM X 22MM X 10MM (PEEK)

    MDR report key: 3131690 · Received May 29, 2013

    Report

    Report Number
    2027467-2013-00012
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 8, 2013
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    MQP
    PMA / PMN Number
    K050553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS BEEN RETURNED FROM THE INTERNATIONAL CUSTOMER AND IS CURRENTLY BEING EVALUATED. A FOLLOW-UP REPORT WITH RESULTS OF THE INVESTIGATION WILL BE SUBMITTED UPON COMPLETION. 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 (B)(4)OR POLYETHERETHERKEYTONE, PEEK (B)(4)A RADIOGRAPHIC MARKER MADE OF TITANIUM (B)(4) OR TANTALUM (B)(4) 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

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE SUSPECT DEVICE REVEALED NO IRREGULARITIES. UPON REVIEW OF X-RAYS AND THE RETURNED BROKEN DEVICE IT WAS DETERMINED THAT THERE WAS INADEQUATE DISK HEIGHT NECESSARY TO RECEIVE THE DEVICE PRIOR TO ATTEMPTING TO INSERT INTO THE DISK SPACE. UNDER NORMAL CIRCUMSTANCES WHERE THERE IS ADEQUATE SPACE BETWEEN THE VERTEBRAL BODIES, THE IMPACTION FORCES EXERTED ON THE DEVICE VIA MALLETING ARE CONVERTED TO MOVEMENT WITHIN THE DISC SPACE. IN THIS INSTANCE WHERE THE SPACE BETWEEN THE VERTEBRAL BODIES WAS NOT ADEQUATE, THE DEVICE MET RESISTANCE AGAINST THE VERTEBRAL BODIES WHEN IMPACTION FORCES WERE APPLIED. THE DEVICE THEN ABSORBED THE FORCES EXERTED ON THE DEVICE RESULTING IN FAILURE BY COMPRESSION DEVICE.

    Description of Event or Problem · 1

    AN INTERNATIONAL CUSTOMER (ISRAEL) REPORTED THAT DURING A TLIF SURGERY ON (B)(6) 2013, A NOVEL PEEK CAGE BROKE AND SEPARATED INTO MULTIPLE PIECES WHILE IMPLANTING. DURING INSERTION, THE SURGEON FELT EXCESSIVE RESISTANCE; THEREFORE, UTILIZED A MALLET TO THRUST THE IMPLANT INTO POSITION. X-RAYS THEN REVEALED THE CAGE DID NOT PASS THE ENDPLATE AS INTENDED. THE FRAGMENTS WERE REMOVED WITH TWEEZERS AND REPLACED WITH A NEW NOVEL SD CAGE. ALTHOUGH THE MULTIPLE SECTIONS OF THE BROKEN CAGE WERE REMOVED WITHOUT ISSUE, IT MAYBE POSSIBLE THAT FRAGMENTS MAY HAVE GOTTEN MIXED WITHIN THE BONE GRAFT AND REMAIN IMPLANTED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234278 SD - PEEK SMALL SPACER - 9MM X 22MM X 10MM (PEEK) MQP MQP ALPHATEC SPINE INC 64813-010 652059

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other