BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEVATE SPINAL SYSTEM

    MDR report key: 10243729 · Received July 8, 2020

    Report

    Report Number
    1030489-2020-00855
    Event Type
    Malfunction
    Date Received
    July 8, 2020
    Date of Event
    July 6, 2020
    Report Date
    July 8, 2020
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    MAX
    UDI-DI
    00643169430778
    PMA / PMN Number
    K172199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #PATIENT DEMOGRAPHICS- INITIALS- (B)(6), GENDER- MALE, AGE (AT THE TIME OF EVENT)- (B)(6), WEIGHT- (B)(6) KG, MEDICAL HISTORY- SPONDYLOLISTHESIS, VP SHUNT, DATE OF IMPLANT- (B)(6) 2020, DATE OF EXPLANT- (B)(6) 2020, DEVICE STATUS- EXPLANTED-COMPLETE. IT WAS REPORTED THAT ON (B)(6) 2020, INTRA-OP, THE ELEVATE CAGE FRACTURED DURING IMPLANTATION. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. UPDATE RECEIVED ON 07 JUL 2020: PRE OP DIAGNOSIS WAS SPONDYLOLISTHESIS AND STENOSIS. PROCEDURE WAS AN L5-S1 MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION (MIS TLIF) NO FRAGMENTS LEFT BEHIND. 510(K) NO: K172199, K142559. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING PATIENT WITH SPONDYLOLISTHESIS,VP SHUNT FOR SPINAL THERAPY. PATIENT DEMOGRAPHICS- INITIALS- (B)(6), GENDER- MALE, AGE (AT THE TIME OF EVENT)- (B)(6), WEIGHT- (B)(6) KG, DATE OF IMPLANT- (B)(6) 2020, DATE OF EXPLANT- (B)(6) 2020, DEVICE STATUS- EXPLANTED-COMPLETE. IT WAS REPORTED EVENT OCCURRED INTRA-OP, THE ELEVATE CAGE FRACTURED DURING IMPLANTATION. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. UPDATE RECEIVED ON 07 JUL 2020: PRE OP DIAGNOSIS WAS SPONDYLOLISTHESIS AND STENOSIS. PROCEDURE WAS AN L5-S1 MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION (MIS TLIF) NO FRAGMENTS LEFT BEHIND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708080 ELEVATE SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX WARSAW ORTHOPEDICS 8880823 0443479W 00643169430778

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR