BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFEOP

    MDR report key: 12021391 · Received June 17, 2021

    Report

    Report Number
    2027467-2021-00040
    Event Type
    Injury
    Date Received
    June 17, 2021
    Date of Event
    May 21, 2021
    Report Date
    May 21, 2021
    Manufacturer
    ALPHATEC SPINE, INC.
    Product Code
    IKD
    UDI-DI
    00190376232287
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B5: THE CLIP WAS NOT PICKING UP ANY READINGS WITH THE INITIAL DILATOR OR ANY OF THE OTHER TWO DILATORS. THE NEEDLES WERE CHANGED, REPLACED ANTERIOR TIBIAL NEEDLE WITH A STICKY PAD, TRIED DIFFERENT CLIPS, DIFFERENT DILATORS, A DIFFERENT SAFEOP UNIT ALL TOGETHER, NOTHING SEEMED TO WORK UNTIL A FOURTH CLIP WAS TRIED WITH A DIFFERENT LOT NUMBER. THERE WAS NO REPORT OF PATIENT INJURY. H6: MEDICAL DEVICE PROBLEM CODE: 2896 (COMMUNICATION OR TRANSMISSION PROBLEM). COMPONENT CODE: 758 (CLIP). TYPE OF INVESTIGATION: 4114 (DEVICE NOT RETURNED); 3331 (ANALYSIS OF PRODUCT RECORDS). INVESTIGATION FINDINGS: 3221 (NO FINDINGS AVAILABLE. INVESTIGATION CONCLUSIONS: 67 (NO PROBLEM DETACHED). H10. REVIEW OF THE DHR INDICATES QTY (B)(4) WERE RECEIVED ON 05/05/2021 AND PASSED INSPECTION PRIOR TO BEING RELEASED INTO INVENTORY. REVIEW OF COMPLAINTS RECORDS INDICATE THIS IS THE ONLY REPORT FOR THIS PN AND LN. NO ADVERSE TREND IDENTIFIED. THE PRODUCT DID NOT RETURN FOR INVESTIGATION. A ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE IS UNABLE TO BE DETERMINED AT THIS TIME. IF ANY ADDITIONAL INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THERE WAS AN ISSUE ENCOUNTERED WHILE PERFORMING PTP WITH A DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911183 SAFEOP IKD IKD ALPHATEC SPINE, INC. AIX1310-S SH211052860 00190376232287

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization