BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCORDE PROTI

    MDR report key: 14652864 · Received June 10, 2022

    Report

    Report Number
    3012966183-2022-00021
    Event Type
    Injury
    Date Received
    June 10, 2022
    Report Date
    June 10, 2022
    Manufacturer
    TYBER MEDICAL
    Product Code
    MAX
    PMA / PMN Number
    K172185
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A HISTORICAL DATA REVIEW ON THE PRODUCT SYSTEM WAS PERFORMED. THERE WERE NO OTHER COMPLAINTS OF THIS TYPE ATTRIBUTED TO THE PRODUCT SYSTEM. THERE WERE NO CAPAS OR NON CONFORMANCES RELATED TO THIS COMPLAINT EVENT AT THE TIME OF THIS INVESTIGATION.

    Description of Event or Problem · 0

    ADVERSE EVENT FROM OUR CLINICAL STUDY THAT WILL NEED TO BE REPORTED. THIS WAS FOR BC008-404 IN THE RETROSPECTIVE LUMBAR FUSION REGISTRY ARM. THIS PATIENT WAS A (B)(6) FEMALE THAT UNDERWENT A TLIF AT L5-S1 WITH THE PROTI CONCORDE BULLET INTERBODY FUSION DEVICE, ALLOGRAFT BONE CHIPS, VIVIGEN VIABLE CELL BONE MATRIX AND THE EXPEDIUM PEDICLE SCREW SYSTEM. AT 2 MONTHS POST-OPERATIVE THE PATIENT HAD AN ADVERSE EVENT. THE PATIENT HAD A DEEP ABSCESS-SEPSIS AT THE LUMBAR SPINE (CLINICAL DIAGNOSIS WAS LUMBAR INFECTION). IT WAS A SINGLE EPISODE, MODERATE IN SEVERITY, AND WAS LIFE THREATENING. THIS EVENT WAS UNANTICIPATED WITH A PROBABLE RELATIONSHIP TO THE PROTI 360O¿ CONCORDE® BULLET INTERBODY FUSION DEVICE. HOSPITALIZATION WAS REQUIRED BUT THE SUBJECT RECOVERED WITHOUT SEQUELAE. AS PART OF TREATMENT THE SUBJECT UNDERWENT ADDITIONAL MRI, BLOOD WORK AND BLOOD CULTURE, PAIN MEDICATION AND ANTIBIOTICS. 2 WEEKS FOLLOWING THE ONSET OF THE ADVERSE EVENT (SO 2.5 MONTHS TOTAL POST-OP) THE PATIENT HAD RE-OPERATION AND DE-BRIDEMENT SURGERY. I'M REACHING OUT FOR MORE DETAILS ON THE SURGERY TO KNOW IF THE INTERBODY FUSION DEVICE WAS REMOVED OR NOT. PLEASE NOTE THE MULTIPLE PRODUCTS THAT WERE INVOLVED WITH THE SURGERY. ANY ONE OF THEM COULD HAVE BEEN ASSOCIATED WITH THE INFECTION. DPS PROBABLY NEEDS TO BE MADE AWARE TOO, AS I THINK THEY MAY NEED TO REPORT ON THEIR NON-PROTI PRODUCTS. HERE IS THE COMPLETE DATA I HAVE FOR THIS PATIENT AT THIS TIME. 78 YEAR OLD FEMALE, OVERWEIGHT, ALLERGIES, ANXIETY/DEPRESSION, HYPERTENSION, HYPOTHYROIDISM, OSTEOPOROSIS, OSTEOPENIA. DIAGNOSED WITH SPONDYLOLISTHESIS, BACK AND LEG PAIN (LEG PAIN GREATER THAN BACK PAIN) UNDERWENT TLIF AT L5-S1 WITH THE PROTI 360O¿ CONCORDE® BULLET INTERBODY FUSION DEVICE (SHORT (9MMX23MM), LORDOTIC (5°), 10MM HEIGHT) WITH ALLOGRAFT BONE CHIPS AND VIVIGEN VIABLE CELL BONE MATRIX AND DEPUY SYNTHES EXPEDIUM PEDICLE SCREW SYSTEM POST-OPERATIVE TREATMENT: PHYSICAL THERAPY (ONCE A WEEK FOR 3 WEEKS). PAIN MEDICATION: TYLENOL (500-1000MG AS NEEDED), OXYCODONE (5-10 MG AS NEEDED) SUBJECT WAS COMPLIANT WITH POST-OPERATIVE INSTRUCTIONS. AT 6 WEEKS FOLLOWING SURGERY THE SUBJECT HAD NOT RETURNED TO NORMAL ACTIVITY: NO BENDING, LIFTING 10 POUNDS, TWISTING X 6 WEEKS AFTER SURGERY. SUBJECT TO AMBULATE DAILY (GOAL OF AT LEAST 30-60 MINUTES A DAY BY 6-WEEK POST OPERATIVE) AT 5-MONTHS POST-OPERATIVE SUBJECT WAS NOT COMPLIANT WITH POST-OPERATIVE TREATMENT (NOT DOING PRESCRIBED PHYSICAL THERAPY). AT 5 MONTHS POST-OPERATIVE SUBJECT HAD EXTREMITY MOTOR SENSORY AND REFLEX DEFICITS ON THE RIGHT SIDE (LOWER EXTREMITY): MOTOR STRENGTH ILIOPSOAS 4/5 QUADRICEP 4/5. SUBJECT HAD NO MOTOR, SENSORY, OR REFLEX DEFICITS BY 10 MONTHS POST-OPERATIVE AT 2 MONTHS POST-OPERATIVE THE SUBJECT HAD AN ADVERSE EVENT. THE SUBJECT HAD A DEEP ABSCESS-SEPSIS AT THE LUMBAR SPINE FUSION (CLINICAL DIAGNOSIS WAS LUMBAR INFECTION). IT WAS A SINGLE EPISODE, MODERATE IN SEVERITY, AND WAS LIFE THREATENING. THIS EVENT WAS UNANTICIPATED WITH A PROBABLE RELATIONSHIP TO THE PROTI 360O¿ CONCORDE® BULLET. INTERBODY FUSION DEVICE. HOSPITALIZATION WAS REQUIRED BUT THE SUBJECT RECOVERED WITHOUT SEQUELAE. AS PART OF TREATMENT THE SUBJECT UNDERWENT ADDITIONAL MRI, BLOOD WORK AND BLOOD CULTURE, PAIN MEDICATION AND ANTIBIOTICS. 2 WEEKS FOLLOWING THE ONSET OF THE ADVERSE EVENT (2.5 MONTHS POST-OP) THE PATIENT HAD RE-OPERATION AND DE-BRIDEMENT SURGERY. SUBJECT RETURNED TO NORMAL ACTIVITY 5-MONTHS POST-OPERATIVE. SPINE PRECAUTIONS LIFTED AT THIS TIME. SUBJECT INSTRUCTED TO PROGRESS ACTIVITIES AS TOLERATED. PRE-OPERATIVE VAS PAIN WAS 50 FOR BACK PAIN, 60 FOR RIGHT LEG PAIN, AND 60 FOR LEFT LEG PAIN. 6-WEEK SCORES WERE 50 FOR BACK PAIN, 70 FOR RIGHT LEG PAIN, NO LEFT LEG PAIN. 3-MONTH SCORES WERE 70 FOR BACK PAIN, 70 FOR RIGHT LEG PAIN, 70 FOR LEFT LEG PAIN. 5-MONTH SCORES WERE 40 FOR BACK PAIN, 70 FOR RIGHT LEG PAIN, AND 70 FOR RIGHT LEG PAIN. 10.5-MONTH SCORES WERE 30 FOR BACK PAIN, 70 FOR RIGHT LEG PAIN, 70 FOR LEFT LEG PAIN. 21-MONTH SCORES WERE 20 FOR BACK PAIN, 80 FOR RIGHT LEG PAIN, 80 FOR LEFT LEG PAIN. PRE-OPERATIVE ODI WAS 32. 6-WEEK SCORE WAS 34. 3-MONTH SCORE WAS 53.3. 5-MONTH SCORE WAS 34, 10.5-MONTH SCORE WAS 40. 21-MONTH SCORE WAS 35.6. SUBJECT FUSED AT 21 MONTHS POST-OPERATIVE WITH GRADE 3 GRAFT INCORPORATION NOTE: PATIENT HAD PRIOR FUSION AT L4-L5. AT THE 21 MONTH FOLLOW-UP THAT FUSION WAS NOTED TO BE FUSED WITH GRADE 2 FUSION (INCOMPLETE GRAFT INCORPORATION). THE INTERBODY FUSION DEVICE WAS NOT A PROTI INTERBODY FUSION DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679620 CONCORDE PROTI INTERBODY SPACERS MAX TYBER MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Other