BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: VEPTR

    MDR report key: 20830741 · Received December 3, 2024

    Report

    Report Number
    8030965-2024-14518
    Event Type
    Injury
    Date Received
    December 3, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    MDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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. H3, H6 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: ADAM JAMNIK, ANNA MCCLUNG-BOOTH, DAVID THORNBERG, PEDIATRIC SPINE STUDY GROUP, BRANDON RAMO. UTILITY OR A RISK SEVERITY SCORING SYSTEM TO PREDICT INFECTIONS IN PATIENTS UNDERGOING GROWTH GUIDANCE SURGERY EARLY ONSET, SPINE DEFORM (2022) 10 (SUPPL 1): S17-S18 PAPER 31. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS RETROSPECTIVE STUDY WAS TO FURTHER ELUCIDATE THE INTERMEDIATE-TERM COMPLICATION PROFILE ASSOCIATED WITH GROWTH FRIENDLY SURGERY IN PRADER-WILLI SYNDROME (PWS) PATIENTS BY ASSESSING SURGICAL CORRECTION OF THE DEFORMITY AND COMPLICATIONS ASSOCIATED. A TOTAL OF 22 PATIENTS MET THE INITIAL INCLUSION CRITERIA. EIGHT PATIENTS WERE EXCLUDED BECAUSE THEY WERE MISSING THE RADIOGRAPHS NECESSARY FOR ANALYSIS, LEAVING 14 PATIENTS WITH ADEQUATE FOLLOW UP AND RADIOGRAPHS TO BE ANALYZED WITH MEAN AGE OF 1.84 YEARS- 8 YEARS OLD, ALL PATIENTS WERE FEMALE. ALL PATIENTS WITH PWS THAT UNDERWENT SURGERY WITH TRADITIONAL GROWING RODS (TGR), MAGNETICALLY CONTROLLED GROWING RODS (MCGR), VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR), OR LUQUE TROLLEY WITH MEAN 4 YEARS FOLLOW UP. 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 RIB (VEPTR). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: VEPTR (B)(4). - (B)(4) PATIENTS UNDERWENT UNPLANNED RETURNS TO THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2292244 UNK - CONSTRUCTS: VEPTR PROSTHESIS, RIB REPLACEMENT MDI SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention