BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICLE SCREW 6X50

    MDR report key: 16032556 · Received December 22, 2022

    Report

    Report Number
    3005180920-2022-00969
    Event Type
    Injury
    Date Received
    December 22, 2022
    Date of Event
    July 17, 2023
    Report Date
    July 21, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWP
    PMA / PMN Number
    K121115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2022: LOT 2221819: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2022. EXPIRATION DATE: 2027-03-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICES INVOLVED: BATCH REVIEWS PERFORMED ON (B)(6) 2022 PEDICLE SCREW 03.50.019 PEDICLE SCREW 6X50 (K121115) LOT 2223937: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2022. EXPIRATION DATE: 2027-05-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. PEDICLE SCREW 03.50.019 PEDICLE SCREW 6X50 (K121115) LOT 2127915: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2022. EXPIRATION DATE: 2027-01-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEADACTA MEDICAL AFFAIRS DIRECTOR: 2 LEVEL LUMBAR FIXATION PERFORMED WITH PEDICLE SCREWS AND (PROBABLY) EXPANDABLE CAGES FROM A DIFFERENT MANUFACTURER. AFTER TWO MONTHS, THE SURGEON CLINICALLY ASSESSED THE PEDICLE SCREW TO HAVE LOST FIXATION AND PURCHASE IN THE BONE. HOWEVER, NO CLINICAL PROBLEMS ARE REPORTED AND THEREFORE NO SURGICAL ACTION IS TAKEN. PROGRESSIVE LOSS OF FIXATION OF PEDICLE SCREWS IS A POSSIBLE ADVERSE EVENT FOLLOWING LUMBAR STABILIZATION, AND IT DOES NOT NECESSARILY END UP IN CLINICAL PROBLEMS - FUSION MAY BE UNDER WAY NONETHELESS. WE SEE NO REASON TO SUSPECT A FAULTY DEVICE AT THE ORIGIN OF THIS COMPLAINT.

    Additional Manufacturer Narrative · 0

    ON 21-JUL-2023 WE RECEIVED INFORMATION ABOUT THE DATE OF THE REVISION ((B)(6) 2023). ALL THE DEVICES WERE REMOVED. THE DEVICES ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE PATIENT CAME IN FOR A POST-OP APPOINTMENT 2 MONTHS AFTER THE PRIMARY AND IT WAS OBSERVED FROM X-RAYS THAT THERE WAS LOST FIXATION OF THE PEDICLE SCREWS. IT IS UNKNOWN IF THE PATIENT WILL BE REVISED.

    Description of Event or Problem · 0

    THE PATIENT CAME IN FOR A POST-OP APPOINTMENT 2 MONTHS AFTER THE PRIMARY AND IT WAS OBSERVED FROM X-RAYS THAT THERE WAS A LOSS OF FIXATION OF THE PEDICLE SCREWS. THE SURGEON REMOVED ALL IMPLANTS ON (B)(6) 2023, 9 MONTHS FROM THE PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2919010 PEDICLE SCREW 6X50 SPINE PEDICLE SCREW KWP MEDACTA INTERNATIONAL SA 03.50.019 2221819

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other| R