BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KWP, MNH, MNI

    MDR report key: 5001690 · Received August 13, 2015

    Report

    Report Number
    2027467-2015-00164
    Event Type
    Injury
    Date Received
    August 13, 2015
    Date of Event
    July 16, 2015
    Report Date
    July 16, 2015
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    KWP
    PMA / PMN Number
    K033090
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO EVALUATION POSSIBLE AT THIS TIME. THE IDENTIFYING PART AND/OR OF NUMBERS OF THE SUSPECT IMPLANTS ARE UNKNOWN AND HAVE NOT BEEN PROVIDED. THE USER FACILITY HAS NOT RELEASED THE EXPLANTED DEVICES. UPON THE RECEIPT OF ADDITIONAL INFORMATION OR THE PRODUCT IN QUESTION, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE ZODIAC SPINAL FIXATION SYSTEM FACILITATES THE SURGICAL CORRECTION OF SPINAL DEFORMITIES BY PROVIDING TEMPORARY INTERNAL FIXATION AND STABILIZATION DURING BONE GRAFT HEALING AND/OR FUSION MASS DEVELOPMENT. THE IMPLANTS ARE MANUFACTURED FROM SURGICAL GRADE TITANIUM ALLOY (TI-6AL-4V ELI OR TI-6AL-4V) OR STAINLESS STEEL (SS 316L). IMPLANT RODS ARE ALSO AVAILABLE IN COMMERCIALLY PURE TITANIUM (TI GRADE 4), TITANIUM ALLOY (TI 6AL 4V ELI), STAINLESS STEEL AND COBALT CHROME (CO-28CR-6MO). ALL HOOKS ARE MADE FROM STAINLESS STEEL (SS 316L) AND TITANIUM ALLOY (TI 6AL 4V ELI). THE ZODIAC SYSTEM IS INTENDED FOR FIXATION/ATTACHMENT TO THE POSTERIOR THORACIC AND LUMBAR SPINE ONLY. IT IS INTENDED THAT THE IMPLANTS BE REMOVED AFTER SUCCESSFUL FUSION. THE ZODIAC SYSTEM MAY BE USED IN CONNECTION WITH ALPHATEC SPINE'S SOLANAS POSTERIOR SYSTEM, WHICH IN TURN CONNECTS WITH AVALON OCCIPITAL PLATE SYSTEM CREATING ADDITIONAL LEVELS OF FIXATION.

    Additional Manufacturer Narrative · 1

    AN EVALUATION RETURNED ZODIAC CONSTRUCT REVEALED NO MANUFACTURING, PROCESSING OR DESIGN RELATED IRREGULARITIES. THE IMPLANTS WERE FOUND TO BE PROPERLY MANUFACTURED AND RELEASED ACCORDING TO DESIGN SPECIFICATIONS. THE EVALUATION CONCLUDED NO PRODUCT PROBLEM EXISTS. THE 62001-50; TI ALLOY STRAIGHT ROD 5.5DIA X 500MM, LOT# 655081, MFG'D 4/18/2013. THE 62065-40; TI STANDARD POLYAXIAL SCREW ASSY 6.5MM X 40MM, LOT# 646204, MFG'D 4/18/2012. THE 22085; ZODIAC TI HEXALOBE SET SCREW, 8.5MM, LOT# 672424, MFG'D 4/3/2014. VISUAL INSPECTION REVEALED THE POLYAXIAL SCREW HAD FRACTURED AND BROKE MID-WAY OF THE THREADED SHAFT. THE RODS CONTOUR HAD AN AGGRESSIVE CURVATURE CONFIRMING THEY WERE BOTH USED IN THE LOWER LUMBAR SPINE WHERE THE GREATEST LOADS FOR IMPLANT SYSTEMS ARE EXPERIENCED. THE FRACTURE LINES ON THE BOTH RODS ARE FAIRLY PERPENDICULAR TO THE CURVATURE WHICH WOULD INDICATE CONTINUAL LOADING OVER TIME LED TO THE FATIGUE OF THE MATERIAL. BOTH THE RODS AND ANCHOR APPEAR TO HAVE BEEN EXPOSED TO FATIGUE STRESSES BEYOND THOSE FOR WHICH IT WAS DESIGNED OR INTENDED. THE PATIENT WAS REPORTED TO HAVE NONUNION AT THE L5-S1 WERE BOTH RODS AND THE POLYAXIAL SCREW FRACTURES ACCRUED. BECAUSE THE PATIENT DID NOT ACHIEVE FUSION THE CONSTRUCT WAS MORE THAN LIKELY CARRYING THE MAJORITY OF THE LOAD THROUGHOUT THE TIME OF IMPLANTATION WITH NO GRADUAL TRANSFER OF LOAD THAT WOULD BE ASSOCIATED WITH FUSION. AS THESE IMPLANTS ARE INTENDED FOR TEMPORARY STABILIZATION UNTIL FUSION OCCURS THEY DO NOT HAVE AN INDEFINITE LIFE AND WILL MOST LIKELY FAIL OVER TIME IF FUSION IS NOT ACHIEVED. THE SUPPLIED INSTRUCTIONS FOR USE (INS-025) WARNING STATES; WARNINGS: THE SYSTEM IMPLANTS ARE USED ONLY TO PROVIDE TEMPORARY INTERNAL FIXATION DURING THE BONE FUSION PROCESS WITH THE ASSISTANCE OF A BONE GRAFT. A SUCCESSFUL RESULT MAY NOT BE ACHIEVED IN EVERY INSTANCE OF USE WITH THESE DEVICES. WITHOUT SOLID BONE FUSION, THESE DEVICES CANNOT BE EXPECTED TO SUPPORT THE SPINE INDEFINITELY AND MAY FAIL DUE TO BONE-METAL INTERFACE, ROD FAILURE OR BONE FAILURE.

    Description of Event or Problem · 1

    REVISION SURGERY WAS CONDUCTED ON (B)(6) 2015 DUE HARDWARE OF A PREVIOUSLY INSTALLED CONSTRUCT WAS FOUND TO CONTAIN BOTH BROKEN AND/OR BACKED OUT IMPLANTS. BOTH ZODIAC RODS LOCATED ON THE RIGHT AND LEFT SIDES OF THE T10-PELVIS FRACTURED AND BROKE. THE RIGHT SIDE WAS BROKEN AT THE S1 AND THE LEFT AT THE L5. BOTH RODS WERE REMOVED AND REPLACED. THE PATIENT HAD A NONUNION FUSION AT BOTH THESE AREA (L5-S1). ADDITIONALLY, THE POLYAXIAL SCREW POSITIONED WITHIN THE L5 PEDICLE HAD ALSO FRACTURED AND GOT BROKEN. IT WAS REMOVED BUT NOT REPLACED. THE 8.5MM SET SCREW LOCATED ON THE LEFT SIDE OF THE ILIAC HAD BACKED-OUT OF POSITION. IT WAS REMOVED AND REPLACED ALONG WITH THE RIGHT SIDE THAT WAS FOUND TO BE SLIGHTLY LOOSE. THE ZODIAC SPINE FIXATION SYSTEM WAS ORIGINALLY INSTALLED AT THE T-10-PELVIS IN (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534570 KWP, MNH, MNI KWP ALPHATEC SPINE INC

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| O