BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACIS PROTI LOR/S 6 MM H

    MDR report key: 20568807 · Received October 30, 2024

    Report

    Report Number
    3012966183-2024-00020
    Event Type
    Injury
    Date Received
    October 30, 2024
    Date of Event
    November 8, 2021
    Report Date
    October 30, 2024
    Manufacturer
    TYBER MEDICAL
    Product Code
    MAX
    UDI-DI
    00819917020656
    PMA / PMN Number
    K172185
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS BEING SUBMITTED FOR AN EVENT THAT WAS IDENTIFIED AS PART OF A HISTORICAL DATA REVIEW COMPARING CLINICAL TRIAL ADVERSE EVENTS WITH THE VIGILANCE SYSTEM. THE EVENT WAS INVESTIGATED WITHOUT THE AFFECTED DEVICE, SPECIFIC LOT INFORMATION, OR KNOWN FINAL OUTCOMES TO THE PATIENT AFTER THEY LEFT THE STUDY. THE DEVICE REMAINED IMPLANTED; THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED. UPON REVIEW OF CLINICAL RECORDS, A SPECIFIED DEVICE MALFUNCTION COULD NOT BE ESTABLISHED, HOWEVER RADIOLUCENCY WAS OBSERVED AROUND THE IMPLANT. FURTHER TREATMENT FOR PAIN AND THE SYMPTOMS COULD NOT BE CLARIFIED, AS PATIENT WAS LOST TO FOLLOW-UP AND DID NOT RETURN TO THE CLINIC. A HISTORICAL DATA ANALYSIS WAS CONDUCTED RETURNING NO RELATED COMPLAINTS, NONCONFORMITIES, OR CAPAS ASSOCIATED WITH THE PART NUMBER. DUE TO INSUFFICIENT INFORMATION REGARDING A SPECIFIC DEVICE DEFECT, THE ROOT CAUSE CANNOT BE ESTABLISHED.

    Description of Event or Problem · 0

    ADVERSE EVENT FROM THE CLINICAL STUDY WHO WAS LOST TO FOLLOW-UP. EVENT DETAILS FROM THE SITE ARE AS FOLLOWS: AT 14-MONTHS POST-OPERATIVE, RADIOGRAPHS DEMONSTRATED SOLID FUSION WITH GRAFT INCORPORATION AT C3-C4 AND C4-C5, HOWEVER C5-C6 WAS NOT FUSED; IMAGING DEMONSTRATED PSEUDARTHROSIS AND RADIOLUCENCY ALONG THE INTERFACE WITH THE VERTEBRAL BODY. ADDITIONALLY, IMAGING DETAILS, SEVERE DISC SPACE NARROWING WITH SEVERE ENDPLATE SCLEROSIS INDICATIVE OF ADJACENT LEVEL DISC DISEASE AT THE LEVEL BELOW FUSION. AT THE 17-MONTH POST-OPERATIVE VISIT, THE SUBJECT REPORTED NECK AND ARM PAIN (ARM>NECK), THE SUBJECT DETAILED THAT THE PAIN RADIATES DOWN HER LEFT SHOULDER LEFT THORACIC FLANK, AND LEFT TRICEPS. THE SUBJECT ALSO REPORTED NUMBNESS AND PARESTHESIA IN THE HAND AND FINGERS. THE SUBJECT WAS GIVEN A STEROID INJECTION IN THE LEFT SHOULDER HOWEVER HAD NO MEANINGFUL PAIN RELIEF. THE SURGEON REPORTED 50-60% IMPROVEMENT FROM THE SURGERY. AT 25-MONTHS POST-OPERATIVE, THE RADIOLUCENCY AT C5-C6 WAS STILL PRESENT, HOWEVER THE SUBJECT DECLINED FURTHER TREATMENT AND THE DEVICE REMAINS. THE SUBJECT DID NOT RETURN TO THE CLINIC AFTER THE 25-MONTH POST-OPERATIVE VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982203 ACIS PROTI LOR/S 6 MM H INTERBODY SPACER MAX TYBER MEDICAL 108843606 00819917020656

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Other