BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SACRAL CANNULATED POLYAXIAL SCREW 6.5MM X 35MM, TI

    MDR report key: 2011096 · Received March 8, 2011

    Report

    Report Number
    2027467-2011-00003
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 15, 2011
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    KWP
    PMA / PMN Number
    K042763
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION CONDUCTED BY AN OUTSIDE INSTITUTION FOUND THAT THE SCREWS FAILED AS A CONSEQUENCE OF UNIDIRECTIONAL BENDING FATIGUE. THIS FAILURE MECHANISM WAS SUPPORTED THE PRESENCE OF MULTIPLE FATIGUE ORIGINS ON ONE SIDE OF EACH SCREW. THE CRACKING PROPAGATED DIRECTLY ACROSS TOWARD THE OTHER SIDE. ONCE THE LOAD COULD NO LONGER BE ACCOMMODATED BY THE REMAINING LIGAMENT, THE CRACKING MECHANISM TRANSITIONED TO DUCTILE OVERLOAD. IN ALL CASES, THE CRACKING INITIATED AT THE FILLET RADIUS ASSOCIATED WITH THE FOURTH THREAD ROOT. THE SEM INSPECTION IDENTIFIED NO OBVIOUS EVIDENCE OF ANY MATERIAL DEFECTS OR ANOMALIES ASSOCIATED WITH THE FATIGUE ORIGINS (THERE WERE NO OBVIOUS INCLUSIONS, FOREIGN MATERIAL, PITS, OR OTHER SURFACE IRREGULARITIES). THE RESULTS SUGGEST THAT THE PRIMARY FACTOR REGARDING THE LOCATION OF FATIGUE CRACK INITIATION WAS THE STRESS CONCENTRATION EFFECT OF THE THREAD ROOT. COMPLETE REPORT ATTACHED. THE SUPPLIED INSTRUCTIONS FOR USE ((B)(4)) PROVIDES WARNING AND POSSIBLE SIDE EFFECTS ASSOCIATED WITH SURGICAL INTERVENTION OF THIS NATURE. WARNINGS# 6 - POTENTIAL RISKS IDENTIFIED WITH THE USE OF THESE DEVICES, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE DEVICE COMPONENT FRACTURE, LOSS OF FIXATION, NON-UNION, FRACTURE OF THE VERTEBRA, NEUROLOGICAL INJURY, VASCULAR OR VISCERAL INJURY. POSSIBLE SIDE EFFECTS# 1- INITIAL OR DELAYED LOOSENING, DISASSEMBLY, BENDING, DISLOCATION AND/OR BREAKAGE OF DEVICE COMPONENTS. TREND ANALYSIS REVEALED THIS OCCURRENCE TO BE AN ISOLATED INCIDENT. UNKNOWN CLINICAL VARIABLES APPEARED TO HAVE ATTRIBUTED TO THIS IRREGULARITY.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION BY MANUFACTURER; AN ANALYSES OF THE PRODUCT IN QUESTION IS CURRENTLY BE CONDUCTED BY AN OUTSIDE INSTITUTION. UPON COMPLETION OF THE EVALUATION AND/OR THE RECEIPT OF ADDITIONAL/UPDATED INFORMATION A FOLLOW-UP REPORT WILL BE SUBMITTED. OTHER TEXT : EVALUATION NOT COMPLETE.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION BY MANUFACTURER; AN ANALYSES OF THE PRODUCT IN QUESTION IS CURRENTLY BE CONDUCTED BY AN OUTSIDE INSTITUTION. UPON COMPLETION OF THE EVALUATION AND/OR THE RECEIPT OF ADDITIONAL/UPDATED INFORMATION A FOLLOW-UP REPORT WILL BE SUBMITTED. EVALUATION NOT COMPLETE.

    Description of Event or Problem · 1

    (B)(6) 2010 - TWO LEVEL ILLICO MIS POSTERIOR FIXATION SYSTEM IMPLANTED IN THE CERVICAL SPINE. (B)(6) 11- SURGICAL INTERVENTION WAS PERFORMED TO REMOVE TWO BROKEN CANNULATED SCREWS ((B)(4)) LOCATED WITHIN THE PATIENTS SACRUM. X-RAY INDICATE BOTH FRACTURES OCCURRED APPROXIMATELY MID-WAY OF THE THREADED SHAFT. NEW ALPHATEC CANNULATED SACRAL SCREWS ((B)(4)) WERE PLACED TO SECURE THE REMAINING CONSTRUCT.

    Description of Event or Problem · 1

    DEVICE 1.(B)(6) 2010 - TWO LEVEL ILLICO MIS POSTERIOR FIXATION SYSTEM IMPLANTED IN THE CERVICAL SPINE.(B)(6) 2011- SURGICAL INTERVENTION WAS PERFORMED TO REMOVE TWO BROKEN CANNUALATED SCREWS (B)(4) LOCATED WITHIN THE PATIENTS SACRUM. X-RAY INDICATE BOTH FRACTURES OCCURRED APPROXIMATELY MID-WAY OF THE THREADED SHAFT. NEW ALPHATEC CANNULATED SACRAL SCREWS (B)(4) WERE PLACED TO SECURE THE REMAINING CONSTRUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SACRAL CANNULATED POLYAXIAL SCREW 6.5MM X 35MM, TI KWP, MNI, MNH KWP ALPHATEC SPINE INC 73965-35 629487

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention P/N 73965-35, LOT# 629153