BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDENTITI ALIF STANDALONE INTERBODY SYSTEM

    MDR report key: 14382238 · Received May 12, 2022

    Report

    Report Number
    2027467-2022-00028
    Event Type
    Injury
    Date Received
    May 12, 2022
    Date of Event
    April 14, 2022
    Report Date
    April 14, 2022
    Manufacturer
    ALPHATEC SPINE, INC
    Product Code
    OVD
    UDI-DI
    00190376299730
    PMA / PMN Number
    K203742
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE BROKEN PORTION OF THE IMPLANT WAS DISCARDED AT THE HOSPITAL. THE IDENTIFYING LOT NUMBER WAS NOT PROVIDED; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. PHOTOGRAPHS OF THE BROKEN IMPLANT WERE NOT PROVIDED NOR WERE DETAILS OF THE PROCEDURE. BASED ON THE INFORMATION PROVIDED, A ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION REGARDING A SUPPLEMENTAL INVESTIGATION CONDUCTED BY ALPAHTEC FOR IDENTITI ALIF INTRAOPERATIVE GRAFT BOLT FAILURES. THE SUPPLEMENTAL INVESTIGATION WAS COMPLETED ON 04-JAN-2023. CORRECTED INFORMATION: D5: HEALTH PROFESSIONAL. H1: MALFUNCTION . H6.MEDICAL DEVICE PROBLEM CODE: 1069. ADDITIONAL INFORMATION: H6: TYPE OF INVESTIGATION: 4102, 3331, 4114. INVESTIGATION FINDINGS: 3243, 4248. INVESTIGATION CONCLUSION: 19, 61. ADDITIONAL INFORMATION: THE GRAFT BOLT IS A COMPONENT OF THE ALPHATEC IDENTITI ALIF STANDALONE INTERBODY SYSTEM, WHICH IS AN INTEGRATED INTERVERTEBRAL BODY FUSION DEVICE FOR USE IN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) PROCEDURES USED IN PATIENTS FOR TREATMENT, NOT DIAGNOSIS. THE BROKEN GRAFT BOLT WAS RETRIEVED FROM THE PATIENT AND DISCARDED AT THE HOSPITAL. PHOTOGRAPHS/RADIOGRAPHS WERE NOT PROVIDED TO CONFIRM THIS EVENT. THE IDENTIFYING LOT NUMBER WAS NOT PROVIDED. THE PATIENT'S BONE QUALITY IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED TO ALPAHTEC REGARDING THIS EVENT. THIS EVENT WAS EVALUATED, AND IT WAS DETERMINED THE ALPHATEC DEVICE MALFUNCTIONED DURING INSERTION. IF THIS EVENT WERE TO REOCCUR, A PORTION OF THE GRAFT BOLT POTENTIALLY COULD BE LEFT IN SITU WHICH MAY REQUIRE SUBSEQUENT SURGICAL INTERVENTION. BASED ON THE INFORMATION PROVIDED, ALPHATEC DETERMINED THIS EVENT IS REPORTABLE TO THE FDA UNDER 21 CFR 803. ALPHATEC CONDUCTED A SUPPLEMENTAL INVESTIGATION FOR INTRAOPERATIVE GRAFT BOLT FAILURES. THE INVESTIGATION INCLUDED SIMULATED USE ACTIVITIES TO REPLICATE FAILURE MODES IN A CONTROLLED SETTING, BOTH IN CADAVERS AND IN SOLID RIGID POLYURETHANE FOAM ("BONE FOAM") AND CONDUCTED ASTM TESTING TO BENCHMARK FAILURE TORQUES AND UNDERSTAND THE POTENTIAL OF FAILURE DURING REASONABLE USE. PHYSICAL CHARACTERIZATION AND INVESTIGATION WERE PERFORMED ON COMPLAINT-RELATED RETURNED MATERIALS, WHERE AVAILABLE. ADDITIONAL TESTING WAS PERFORMED ON MATERIAL, NOT DISTRIBUTED, TO REPLICATE THE FAILURE. THE GRAFT BOLT IS DESIGNED TO WITHSTAND AN INSERTION TORQUE CONSISTENT WITH ON-TRAJECTORY INSERTION (40°) INTO A RANGE OF BONE QUALITIES REPRESENTATIVE OF THE PATIENT POPULATION. MECHANICAL TESTING PERFORMED AS A PART OF THE ROOT CAUSE INVESTIGATION FOR THESE REPORTED INTRAOPERATIVE FAILURES DEMONSTRATES THAT THE DEVICE MEETS PERFORMANCE SPECIFICATIONS REQUIRED FOR THIS DEVICE. BOTH THE TORQUE REQUIRED TO FAIL THE GRAFT BOLT IN TORSION AND THE LOAD REQUIRED TO FAIL THE GRAFT BOLT IN CANTILEVER BENDING ARE GREATER THAN THOSE REQUIRED TO FAIL A MORE CONVENTIONAL SCREW COMMON TO INTERFIXATED LUMBAR INTERBODY FUSION PROCEDURES. THE FOLLOWING CONCLUSIONS OF THE GRAFT BOLT INTRAOPERATIVE FAILURE WERE DRAWN FROM THE RESULTS OF THE INVESTIGATION: THE FAILURES WERE NOT THE RESULT OF MANUFACTURING DEFECTS, AS NO MANUFACTURING DEFECTS WERE IDENTIFIED IN THE DEVICE HISTORY REVIEW. THE FAILURES WERE NOT THE RESULT OF NORMAL USE OF THE GRAFT BOLT AS PRESCRIBED IN THE SURGICAL TECHNIQUE. THE GRAFT BOLT WAS SUCCESSFULLY DESIGNED TO WITHSTAND MUCH GREATER TORQUES THAN THE INSERTION TORQUE INTO NORMAL BONE; THIS IS REFLECTED IN BOTH THE STIMULATED USE ACTIVITIES AND THE VARIOUS MECHANICAL TEST CONDUCTED. THE FAILURES WERE NOT THE RESULT OF A PERFORMANCE DEFICIENCY IN THE GRAFT BOLT AS COMPARED TO A MORE CONVENTIONAL SCREW DESIGN; INDEED, THE GRAFT BOLT IS COMPARABLE TO A CONVENTIONAL SCREW IN INSERTION TORQUE AND OUTPERFORMS A CONVENTIONAL SCREW IN TORSIONAL AND BENDING FAILURE MODES. THE FAILURES WERE PRIMARILY CAUSED BY USE ERROR. GROSS DEVIATION FROM THE PRESCRIBED GRAFT BOLT INSERTION TRAJECTORY CAUSED THE GRAFT BOLT TO IMPINGE ON THE POSTERIOR END OF THE MEDIAL SCREW HOLE OR THE POSTERIOR WALL OF THE INTERBODY SPACER. THE USERS THEN DID NOT REACT TO THE INCREASE IN INSERTION TORQUE AS THEY WOULD HAVE WITH A CONVENTIONAL SCREW DESIGN. WITH THE GRAFT BOLT ENGAGED IN THE POROUS TITANIUM OF THE INTERBODY SPACER, INSERTION TORQUE COULD INCREASE UNTIL FAILURE TORQUE FOR THE GRAFT BOLT WAS REACHED, RESULTING IN SHEAR FAILURE. AS A RESULT OF THE SUPPLEMENTAL INVESTIGATION, ALPHATEC HAS IMPLEMENTED LABELING CHANGES IN THE SURGICAL TECHNIQUE GUIDE AND THE INSTRUCTIONS FOR USE, PRESCRIBING THE USE OF HOLE PREPARATION INSTRUMENTS, CAUTIONING AGAINST OFF-TRAJECTORY INSERTION, AND WARNING OF POTENTIAL DEVICE FAILURE IN OFF-TRAJECTORY INSERTION CONDITIONS. ON JANUARY 10, 2023, A FIELD BULLETIN WAS SENT ALPHATEC SALES FORCE AND CUSTOMER SERVICE NOTIFYING THEM OF THE CHANGES. LABELING REVIEW: "WARNINGS/CAUTIONS/PRECAUTIONS: CARE SHOULD BE TAKEN IN PERFORMING SCREW HOLE PREPARATION TO FACILITATE A PROPER GRAFT BOLT INSERTION TRAJECTORY AND IMPLANTATION. CONFIRM UNDER FLUOROSCOPY THAT THE GRAFT BOLT INSERTION ANGLE IS AS CLOSE AS POSSIBLE TO A 40° TRAJECTORY. A SHALLOW OR INCORRECT GRAFT BOLT TRAJECTORY MAY RESULT IN ENCROACHMENT OF THE SPACER AND LEAD TO GRAFT BOLT BREAKAGE." ON -05-DEC-2022, THE FDA SENT ALPHATEC ADDITIONAL INFORMATION REQUEST FOR THIS MDR. ALPHATEC RESPONDED TO THE FDA ON 13-JAN-20.

    Description of Event or Problem · 0

    ON (B)(6) 2022, AN IDENTITI ALIF SA GRAFT BOLT BROKE DURING INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580405 IDENTITI ALIF STANDALONE INTERBODY SYSTEM INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR OVD ALPHATEC SPINE, INC 132-10-85-300 00190376299730

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other