BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - VEPTR IMPLANTS: PARALLEL CONNECTOR

    MDR report key: 20724029 · Received November 19, 2024

    Report

    Report Number
    8030965-2024-14119
    Event Type
    Injury
    Date Received
    November 19, 2024
    Date of Event
    November 7, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    MDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. 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 LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: LI M, ALHANI B, NEWTON-EDE M, MARKS D, JONES M. PATIENT-SPECIFIC 3D PRINTING TO REPLACE COMPONENTS OF A RIB-TO PELVIS "EIFFEL TOWER" VERTEBRAL EXPANDING PROSTHETIC TITANIUM RIB SYSTEM IN AN INFANT: A CASE REPORT. EUR SPINE J. 2023 JUL;32(7):2607-2614. DOI: 10.1007/S00586-022-07460-Z. EPUB 2022 NOV 27. PMID: 36436085. OBJECTIVE/METHODS/STUDY DATA: THE PURPOSE OF THIS CASE REPORT WAS TO DEMONSTRATE THE SUCCESSFUL APPLICATION OF PATIENT-SPECIFIC 3D-PRINTED MODELS (3D-PMS) IN ADDRESSING ANATOMICAL CHALLENGES DURING COMPLEX AND REVISION SPINAL SURGERIES. SPECIFICALLY, IT REPORTS THE USE OF A 3D-PM IN THE TREATMENT OF A WOUND BREAKDOWN OVER A COMPONENT OF A VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR) SYSTEM, NECESSITATING THE REPLACEMENT OF THE DUNN-MCCARTHY HOOK AND SLEEVE WITH PATIENT-SPECIFIC CONTOURED COMPONENTS BASED ON THE 3D-PM OF THE SPINE. IN SEPTEMBER 2018, A TWO-YEAR-OLD BORN WITH MYELOMENINGOCELE (MMC), REPAIRED AT BIRTH, DEVELOPED PROGRESSIVE MMC-ASSOCIATED KYPHOSCOLIOSIS. THE PATIENT UNDERWENT INSERTION OF BILATERAL VEPTR (DEPUY SYNTHES) RIB-TO-PELVIS ¿EIFEL TOWER¿ CONSTRUCTS UTILISING DUNNMCCARTHY HOOKS ONTO THE ILIAC WING. PROXIMAL FIXATION WAS ACHIEVED AT THE THIRD AND FOURTH RIBS BILATERALLY WITH A CROSS CONNECTOR, WITH A SIX-HOLE VEPTR SLEEVE WITH EXTENSION SIZE 9 AND 220 MM RADIUS INSERT. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES VEPTR. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: VEPTR (QTY 1). WOUND HEALING WAS DELAYED AND ULTIMATELY BROKE DOWN DESPITE TOPICAL NEGATIVE PRESSURE DRESSINGS AND ANTIBIOTICS, LEAVING A 4X3 CM DEFECT REQUIRING SURGICAL EXPLORATION AT EXACTLY SEVEN WEEKS (42ND DAY). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - VEPTR IMPLANTS: RIB HOOK (QTY 1). THE RIGHT VEPTR SLEEVE, DUNN-MCCARTHY HOOK AND ROD-TO-ROD SIDE CONNECTOR WAS FOUND TO COMMUNICATE WITH THE WOUND AND WERE REMOVED WITH FURTHER TOPICAL NEGATIVE PRESSURE DRESSING APPLIED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - VEPTR IMPLANTS: RIB SLEEVE (QTY 1). THE RIGHT VEPTR SLEEVE, DUNN-MCCARTHY HOOK AND ROD-TO-ROD SIDE CONNECTOR WAS FOUND TO COMMUNICATE WITH THE WOUND AND WERE REMOVED WITH FURTHER TOPICAL NEGATIVE PRESSURE DRESSING APPLIED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - VEPTR IMPLANTS: PARALLEL CONNECTOR (QTY 1). THE RIGHT VEPTR SLEEVE, DUNN-MCCARTHY HOOK AND ROD-TO-ROD SIDE CONNECTOR WAS FOUND TO COMMUNICATE WITH THE WOUND AND WERE REMOVED WITH FURTHER TOPICAL NEGATIVE PRESSURE DRESSING APPLIED. THE SEVERITY OF HIS STARTING KYPHOTIC DEFORMITY, COUPLED WITH THE INHERENT PROMINENCE OF THE IMPLANTS, LED TO THE DELAYED WOUND BREAKDOWN, AGGRAVATED BY THE CROSS CONNECTOR, WHICH BY NATURE IS A MIDLINE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42191 UNK - VEPTR IMPLANTS: PARALLEL CONNECTOR PROSTHESIS, RIB REPLACEMENT MDI SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 24 MO Unknown Required Intervention