BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BC DISTRACTOR BODY END ACT 35MM FOR CMF DISTRACTOR

    MDR report key: 22736335 · Received August 7, 2025

    Report

    Report Number
    8030965-2025-08113
    Event Type
    Malfunction
    Date Received
    August 7, 2025
    Date of Event
    July 11, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    PBJ
    UDI-DI
    10887587015477
    PMA / PMN Number
    K170818
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL NARRATIVE: D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11 ADDITIONAL NARRATIVE: H6 COMPONENT CODES: MOST RELEVANT COMPONENT CODE IS G07002 (APPROPRIATE TERM/CODE NOT AVAILABLE) TO CAPTURE NO FINDINGS AVAILABLE DUE TO NO PRODUCT RETURNED. H3, H6: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ACCORDING THE SURGEON, THE TURNING SCREW ON THE BC DISTRACT BODY, END-ACTIVATED (END-TRANSLATING) BROKE WHILE TURNING DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2005791 BC DISTRACTOR BODY END ACT 35MM FOR CMF DISTRACTOR CRANIAL DISTRACTION SYSTEM PBJ SYNTHES GMBH 10887587015477

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown