BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: VEPTR

    MDR report key: 20771498 · Received November 25, 2024

    Report

    Report Number
    8030965-2024-14331
    Event Type
    Injury
    Date Received
    November 25, 2024
    Date of Event
    February 8, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    MDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. 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. 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. 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: YOKOGAWA N, DEMURA S, OHARA T, TAUCHI R, TAKIMURA K, YANAGIDA H, YAMAGUCHI T, WATANABE K, SUZUKI S, UNO K, SUZUKI T, WATANABE K, KOTANI T, NAKAYAMA K, OKU N, TANIGUCHI Y, MURAKAMI H, YAMAMOTO T, KAWAMURA I, TAKESHITA K, SUGAWARA R, KIKKAWA I, KAWAKAMI N. INSTRUMENTATION FAILURE FOLLOWING PEDIATRIC SPINE DEFORMITY GROWTH-SPARING SURGERY USING TRADITIONAL GROWING RODS OR VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIBS. BMC MUSCULOSKELET DISORD. 2024 FEB 8;25(1):115. DOI: 10.1186/S12891-024-07211-9. PMID: 38331756; PMCID: PMC10851562. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS RETROSPECTIVELY STUDY WAS TO EVALUATE THE INCIDENCE, TIMING, AND RATES OF UNPLANNED RETURN TO THE OPERATING ROOM (UPROR) ASSOCIATED WITH IF FOLLOWING EACH SURGICAL PROCEDURE IN GROWTH-SPARING SURGERIES USING TRADITIONAL GROWING RODS (TGRS) AND VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIBS (VEPTRS). BETWEEN (B)(6) 2015 AND (B)(6) 2017, A TOTAL OF (B)(4) GROWTH-SPARING SURGERIES. OF THESE, (B)(4) PROCEDURES IN (B)(4) PATIENTS WERE REGISTERED AS TRADITIONAL GROWING ROD TECHNIQUE (TGRS) ((B)(4)) WITH THE AVERAGE AGE OF 9.8 YEARS AND (B)(4) PATIENTS AS VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB TECHNIQUE (VEPTRS) ((B)(4)) WITH THE AVERAGE AGE OF 8.4 YEARS. THE MINIMUM FOLLOW-UP WAS 2 YEARS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: UNKNOWN SYNTHES VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIBS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - VEPTR IMPLANTS: RIB HOOK ((B)(4)). (B)(4) CASES OF ANCHOR LOOSENING/DISLOCATION. TIMING OF REVISION SURGERY WERE (B)(4) ELECTIVE, (B)(4) CONSEQUENTIAL AND (B)(4) UNPLANNED RETURNS TO THE OPERATING ROOM. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - RODS: VEPTR ((B)(4)). (B)(4) CASES OF ROD BREAKAGE. TIMING OF REVISION SURGERY WERE (B)(4) CONSEQUENTIAL AND (B)(4) UNPLANNED RETURN TO THE OPERATING ROOM. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - VEPTR IMPLANTS ((B)(4)). (B)(4) CASES OF IMPLANT PROTRUSION. TIMING OF REVISION SURGERY WERE (B)(4) ELECTIVE AND (B)(4) UNPLANNED RETURN TO THE OPERATING ROOM. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: VEPTR ((B)(4)). (B)(4) CASE OF PROXIMAL JUNCTIONAL KYPHOSIS. TIMING OF REVISION SURGERY WERE (B)(4) ELECTIVE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1630410 UNK - CONSTRUCTS: VEPTR PROSTHESIS, RIB REPLACEMENT MDI SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention