BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - DISTRACTOR IMPLANTS: CRANIOMAXILLOFACIAL

    MDR report key: 20532358 · Received October 25, 2024

    Report

    Report Number
    8030965-2024-13214
    Event Type
    Injury
    Date Received
    October 25, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    PBJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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. H6 COMPONENT CODES: MOST RELEVANT COMPONENT CODE IS G07002 (APPROPRIATE TERM/CODE NOT AVAILABLE) TO CAPTURE NO FINDINGS AVAILABLE DUE TO NO PRODUCT RETURNED. INVESTIGATION SUMMARY : 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE DUA SUMMARIZES 15 PATIENTS WHO UNDERWENT SURGERY USING CMF-D DISTRACTOR (CRANIAL INDICATION) AT (B)(6). PATIENT C10: 5-YEAR-OLD MALE: THE PATIENT UNDERWENT 1. BARREL STAVE OSTEOTOMIES, CRANIAL BASE, 2. APPLY RIGHT AND LEFT 2.0 SYSTEM, 35 MM LENGTH CRANIAL DISTRACTORS, 3. PLACEMENT OF RIGHT AND LEFT 30 MM LENGTH DEPUY SYNTHES 1.5 SYSTEM DISTRACTOR. POST OP COMPLICATION INCLUDED PAIN AND DISCOMFORT, AND AT 15 DAYS POST-SURGERY, THE RIGHT DISTRACTOR ARM FELL AND WAS REPLACED. IMPLANT(S) INVOLVED: 30MM FLEXIBLE EXTENSION ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945187 UNK - DISTRACTOR IMPLANTS: CRANIOMAXILLOFACIAL CRANIAL DISTRACTION SYSTEM PBJ SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Male Required Intervention