BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S4 SET SCREW NEW VERSION

    MDR report key: 22386156 · Received July 2, 2025

    Report

    Report Number
    9610612-2025-00130
    Event Type
    Injury
    Date Received
    July 2, 2025
    Report Date
    July 31, 2025
    Manufacturer
    AESCULAP AG
    Product Code
    MNI
    PMA / PMN Number
    K032219
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H6 - CODES UPDATED. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS CONSIDERED NO LONGER REPORTABLE FOR THE FOLLOWING REASONS: - NO SERIOUS PUBLIC HEALTH THREAT / FALSIFIED PRODUCT. - NO SERIOUS INCIDENT. - THE INVESTIGATION RESULTS REVEALED THAT THE PRODUCT WORKED AS INTENDED. INVESTIGATION FINDINGS: THE COMPLAINED PRODUCTS WERE NOT AVAILABLE FOR INVESTIGATION. ACCORDING TO THE COMPLAINT DESCRIPTION AND AFTER EVALUATING THE AVAILABLE INFORMATION, THE PRODUCT(S) WORKED AS EXPECTED. THE FUSION OF THE VERTEBRAE PROCEEDED AS EXPECTED; NO DEFECT OR MALFUNCTION OF ANY OF THE IMPLANTS WAS REPORTED. REMOVAL OF THE IMPLANTS AFTER FUSION CAN BUTDOES NOT HAVE TO BE CARRIED OUT. BATCH HISTORY REVIEW: DUE TO THE FACT THAT NO LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE COMPLAINED DEVICE IS NOT POSSIBLE. EVEN AFTER FAITHFUL ATTEMPTS, NO FURTHER INFORMATION WAS RECEIVED. CONCLUSION/PREVENTIVE MEASURES: ACCORDING TO THE COMPLAINT DESCRIPTION THERE IS NO PRODUCT FAILURE AND NO PRODUCT RELATED PROBLEM. IN THE EVENT THAT THE COMPLAINT PRODUCT WILL BE PROVIDED FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH SW790T - S4 SET SCREW NEW VERSION. ACCORDING TO THE COMPLAINT DESCRIPTION, IMPLANTS WERE TO BE REMOVED DURING A REVISION SURGERY. THE PATIENT HAD FULLY FUSED AND ANATOMY HAD FULLY HEALED. THE SURGEON AND PATIENT AGREED ON THE S4 LUMBAR PEDICLE SYSTEM REMOVAL. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASON - ADVERSE EVENT (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS ADVERSE EVENT WAS BASED ON THE PATIENT HARM, REVISION SURGERY. ADDITIONAL INFORMATION WAS NOT PROVIDED BUT HAS BEEN REQUESTED. THE ADVERSE EVENT IS FILED UNDER AESCULAP AG REFERENCE NO. (B)(4). ASSOCIATED MEDWATCH REPORTS: SW779T/ S4 POLYAXIAL SCREW 6.0X60MM (AESCULAP AG REFERENCE NO. (B)(4). SW779T/ S4 POLYAXIAL SCREW 6.0X60MM (AESCULAP AG REFERENCE NO. (B)(4). SW778T/ S4 POLYAXIAL SCREW 6.0X55MM (AESCULAP AG REFERENCE NO. (B)(4). SW778T/ S4 POLYAXIAL SCREW 6.0X55MM (AESCULAP AG REFERENCE NO. (B)(4). SW656T/ S4 PRE-BENT ROD 5.5X45MM (AESCULAP AG REFERENCE NO. (B)(4). SW656T/ S4 PRE-BENT ROD 5.5X45MM (AESCULAP AG REFERENCE NO. (B)(4). SW790T/ S4 SET SCREW NEW VERSION (AESCULAP AG REFERENCE NO. (B)(4). SW790T/ S4 SET SCREW NEW VERSION (AESCULAP AG REFERENCE NO. (B)(4). SW790T/ S4 SET SCREW NEW VERSION (AESCULAP AG REFERENCE NO. (B)(4). SW790T/ S4 SET SCREW NEW VERSION (AESCULAP AG REFERENCE NO. (B)(4).

    Description of Event or Problem · 0

    ASSOCIATED MEDWATCH REPORTS: SW779T/ S4 POLYAXIAL SCREW 6.0X60MM (AESCULAP AG REFERENCE NO.(B)(4): 9610612-2025-00121), SW779T/ S4 POLYAXIAL SCREW 6.0X60MM (AESCULAP AG REFERENCE NO.(B)(4): 9610612-2025-00122), SW778T/ S4 POLYAXIAL SCREW 6.0X55MM (AESCULAP AG REFERENCE NO.(B)(4): 9610612-2025-00123), SW778T/ S4 POLYAXIAL SCREW 6.0X55MM (AESCULAP AG REFERENCE NO.(B)(4): 9610612-2025-00124), SW656T/ S4 PRE-BENT ROD 5.5X45MM (AESCULAP AG REFERENCE NO.(B)(4): 9610612-2025-00125), SW656T/ S4 PRE-BENT ROD 5.5X45MM (AESCULAP AG REFERENCE NO.(B)(4): 9610612-2025-00126), SW790T/ S4 SET SCREW NEW VERSION (AESCULAP AG REFERENCE NO.(B)(4): 9610612-2025-00127), SW790T/ S4 SET SCREW NEW VERSION (AESCULAP AG REFERENCE NO.(B)(4): 9610612-2025-00128), SW790T/ S4 SET SCREW NEW VERSION (AESCULAP AG REFERENCE NO.(B)(4): 9610612-2025-00129), SW790T/ S4 SET SCREW NEW VERSION (AESCULAP AG REFERENCE NO.(B)(4): 9610612-2025-00130).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142227 S4 SET SCREW NEW VERSION SPINE SURGERY MNI AESCULAP AG SW790T

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention