BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPF-XL IIB 2/DM

    MDR report key: 16991739 · Received May 24, 2023

    Report

    Report Number
    0002242816-2023-00054
    Event Type
    Injury
    Date Received
    May 24, 2023
    Report Date
    July 30, 2024
    Manufacturer
    EBI, LLC.
    Product Code
    LOE
    UDI-DI
    00812301020089
    PMA / PMN Number
    P850035/S023
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT (B)(4). DATE OF EVENT: THE EVENT OCCURRED SOMETIME IN (B)(6) 2023. MEDICAL PRODUCT: UNKNOWN. THERAPY DATE: UNKNOWN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE DEVICE WAS NOT RETURNED TO HIGHRIDGE MEDICAL FOR EVALUATION. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. HIGHRIDGE MEDICAL WILL CONTINUE TO MONITOR FOR TREND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S SPF WAS EXPLANTED DUE TO PAIN. THE PATIENT'S IMPLANT DATE WAS (B)(6) 2022 AT HMH BAYSHORE MEDICAL CENTER. THE IMPLANTED SPF WAS SPF XL IIB, 2/DM - 10-1335M, SERIAL NUMBER (B)(6). ADDITIONAL CONTACT AND DEMOGRAPHIC DETAILS ON THE PATIENT ARE NOT AVAILABLE. ADDITIONAL DETAILS ON THE PATIENT'S EXPERIENCE ARE NOT AVAILABLE. NO REPLACEMENTS TO OUR KNOWLEDGE. THE PATIENT STATED, "WE BELIEVE THE WIRE BROKE AFTER A REAR END MVA ABOUT A YEAR AFTER IMPLANTATION. MY SURGEON DID TAKE OUT THE BATTERY PART OF THE TIME. BUT THE CATHODES ARE STILL IN MY CERVICAL AREA. THE PATIENT STATED THAT THE ISSUE IS GETTING A FACILITY TO TAKE AN MRI NEEDED OF MY HIP AND ELBOW AREA. THE PATIENT WAS TOLD TO CONTACT ZIMVIE. THE PATIENT WAS NOT SENT A REPLACEMENT PRODUCT. THE PRODUCT IS NOT EXPECTED TO BE RETURN. NO ADDITIONAL INFORMATION WAS PROVIDED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S SPF WAS EXPLANTED DUE TO PAIN. THE PATIENT'S IMPLANT DATE WAS ON (B)(6) 2022 AT (B)(6) MEDICAL CENTER. THE IMPLANTED SPF WAS SPF XL IIB, 2/DM - 10-1335M, SERIAL NUMBER (B)(6). ADDITIONAL CONTACT AND DEMOGRAPHIC DETAILS ON THE PATIENT ARE NOT AVAILABLE. ADDITIONAL DETAILS ON THE PATIENT'S EXPERIENCE ARE NOT AVAILABLE. NO REPLACEMENTS TO OUR KNOWLEDGE. THE PATIENT STATED, "WE BELIEVE THE WIRE BROKE AFTER A REAR END MVA ABOUT A YEAR AFTER IMPLANTATION. MY SURGEON DID TAKE OUT THE BATTERY PART OF THE TIME. BUT THE CATHODES ARE STILL IN MY CERVICAL AREA. THE PATIENT STATED THAT THE ISSUE IS GETTING A FACILITY TO TAKE AN MRI NEEDED OF MY HIP AND ELBOW AREA. THE PATIENT WAS TOLD TO CONTACT ZIMVIE. THE PATIENT WAS NOT SENT A REPLACEMENT PRODUCT. THE PRODUCT IS NOT EXPECTED TO BE RETURN. NO ADDITIONAL PATIENT CONSEQUENCES/ FURTHER INFORMATION HAS BEEN REPORTED. THE SPF XL IIB WAS NOT RETURNED FOR FURTHER EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1648797 SPF-XL IIB 2/DM SPF LOE EBI, LLC. N/A N/A 00812301020089

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Required Intervention| S SEE H10 NARRATIVE| SEE H10 NARRATIVE.