BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POST IBF HI H 9MM 4DEG 26/9

    MDR report key: 11745947 · Received April 29, 2021

    Report

    Report Number
    3013730328-2021-00012
    Event Type
    Malfunction
    Date Received
    April 29, 2021
    Date of Event
    April 1, 2021
    Report Date
    April 6, 2021
    Manufacturer
    EIT EMERGING IMPLANT TECHNOLOGIES GMBH
    Product Code
    MAX
    UDI-DI
    04260557822449
    PMA / PMN Number
    K170503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #(B)(4). UDI UNKNOWN (OTHER): WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. INVESTIGATION SUMMARY: BACKGROUND. CAGE COULD NOT BE DISCONNECTED FROM THE CAGE HOLDER. CAGE HOLDER ALSO BROKEN AT THE DISTAL END OF THE INSTRUMENT. INSTRUMENT AND CAGE WERE REMOVED AND REPLACED BY ANOTHER INSTRUMENT AND CAGE. SURGERY DELAY: 10MIN. NO ADVERSE PATIENT HARM. SURGERY COMPLETED SUCCESSFULLY. THIS COMPLAINT INVOLVES TWO (2) DEVICES. CUSTOMER QUALITY INVESTIGATION: THE IMPLANT(S) WAS NOT RETURNED, AND THE INVESTIGATION WILL BE COMPLETED BASED ON THE SUPPLIED IMAGE(S) LOCATED IN PC'S ATTACHMENTS SECTION RECEIVED THROUGH 06APR2021. THE IMAGE(S) WAS REVIEWED, AND THE COMPLAINT CONDITION WAS CONFIRMED, AS IT APPEARS THE CAGE IS SEIZED ON THE INSTRUMENT AND WILL NOT DETACH. AS THE IMPLANT(S) WAS NOT RETURNED AND AS RECEIVED, DIMENSIONAL, MATERIAL OR DRAWING REVIEWS ARE NOT APPLICABLE. A MANUFACTURING RECORD EVALUATION COULD NOT VE PERFORMED AS THE LOT NUMBER COULD NOT BE DETERMINED FROM THE IMAGE. CONCLUSION: THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT AS THE CIRCUMSTANCES DURING THE TIME OF THE EVENT ARE UNKNOWN. NO NEW MALFUNCTIONS WERE OBSERVED DURING THIS INVESTIGATION THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. DEVICE HISTORY REVIEW A MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED AS THE LOT NUMBER COULD NOT BE DETERMINED FROM THE IMAGE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A CAGE COULD NOT BE DISCONNECTED FROM THE CAGE HOLDER. THE CAGE HOLDER ALSO BROKEN AT THE DISTAL END OF THE INSTRUMENT, THE INSTRUMENT AND CAGE WERE REMOVED AND REPLACED BY ANOTHER INSTRUMENT AND CAGE. THERE WAS A SURGERY DELAY OF 10MIN. NO ADVERSE PATIENT HARM AND SURGERY WAS COMPLETED SUCCESSFULLY. THIS COMPLAINT INVOLVES TWO (2) DEVICES (1). THIS REPORT IS FOR ONE (1) POST IBF HI H 9MM 4DEG 26/9. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641981 POST IBF HI H 9MM 4DEG 26/9 INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX EIT EMERGING IMPLANT TECHNOLOGIES GMBH 04260557822449

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown POST IBF HI H 9MM 4DEG 26/9| T-HANDLE INSERTER| POST IBF HI H 9MM 4DEG 26/9| T-HANDLE INSERTER