BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN COBLATION SPORTSMED DEV

    MDR report key: 13995679 · Received April 4, 2022

    Report

    Report Number
    3006524618-2022-00169
    Event Type
    Injury
    Date Received
    April 4, 2022
    Date of Event
    July 1, 2021
    Report Date
    May 17, 2022
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K202006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE (B)(4). ARTICLE CITATION: YIN H, ZHANG X, HUANG Z, SONG Y, ZHU Q. EFFICACY OF SINGLE LEVEL VERSUS DOUBLE LEVELS SURGERY OF PERCUTANEOUS DISC NUCLEOPLASTY (PDN) APPROACH IN TREATING LUMBAR DISC HERNIATION. MED SCI MONIT. 2021 JUL 29;27:E930000. DOI: 10.12659/MSM.930000. PMID: 34321453; PMCID: PMC8330383.

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION, THUS VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED AND THUS A MANUFACTURING RECORD REVIEW, IFU/DEVICE LABELING REVIEW AND RISK MANAGEMENT REVIEW COULD NOT BE CONDUCTED. A COMPLAINT HISTORY REVIEW FOUND NO SIMILAR REPORTED EVENTS. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. THERE WAS NO WAY TO DETERMINE IF THE DEVICE CONTRIBUTED TO THE REPORTED EVENT. THE COMPLAINT WAS NOT CONFIRMED, AND THE ROOT CAUSE COULD NOT BE DETERMINED. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR RECOMMENDATIONS ON PROPER USE OF THE DEVICE AND POTENTIAL TROUBLESHOOTING METHODS TO PREVENT FUTURE REOCCURRENCE OF THE REPORTED EVENT. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. IF THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED AT A FUTURE DATE, THIS INVESTIGATION WILL BE REOPENED FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON LITERATURE REVIEW EFFICACY OF SINGLE LEVEL VERSUS DOUBLE LEVELS SURGERY OF PERCUTANEOUS DISC NUCLEOPLASTY (PDN) APPROACH IN TREATING LUMBAR DISC HERNIATION, 12 PATIENTS HAD COMPLICATIONS AFTER A PERCUTANEOUS DISC NUCLEOPLASTY PROCEDURE USING A PERC DLG SPINE COBLATION WAND. AFTER SOME UNKNOWN COMPLICATIONS, 3 PATIENTS REQUIRED REOPERATION OF DISCECTOMY, 4 PATIENTS REQUIRED REOPERATION OF DECOMPRESSION AND 5 PATIENTS REQUIRED REOPERATION OF SPONDYLODESIS. PATIENTS OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81933 UNKN COBLATION SPORTSMED DEV ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ARTHROCARE CORP. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention