BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: VEPTR

    MDR report key: 20835407 · Received December 3, 2024

    Report

    Report Number
    8030965-2024-14547
    Event Type
    Injury
    Date Received
    December 3, 2024
    Date of Event
    November 13, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    MDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H11: ADDITIONAL NARRATIVE: B3: EXACT DATE OF EVENT IS UNKNOWN; NOVEMBER 13, 2023 IS THE DATE THE LITERATURE ARTICLE WAS PUBLISHED. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS 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. 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. 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: SHAMS K, JHA S, SWALLOW J, CAIRD MS, FARLEY FA, STEPANOVICH M, LI Y. SERUM TITANIUM LEVELS REMAIN ELEVATED BUT URINE TITANIUM IS UNDETECTABLE IN CHILDREN WITH EARLY ONSET SCOLIOSIS UNDERGOING GROWTH-FRIENDLY SURGICAL TREATMENT: A PROSPECTIVE STUDY. J PEDIATR ORTHOP. 2024 JAN 1;44(1):37-42. DOI: 10.1097/BPO.0000000000002565. EPUB 2023 NOV 13. PMID: 37953656. OBJECTIVE/METHODS/STUDY DATA: THE PURPOSE OF THIS PROSPECTIVE CASE-CONTROL STUDY WAS TO COMPARE SERUM TITANIUM LEVELS IN PATIENTS WITH EARLY ONSET SCOLIOSIS EOS TREATED WITH TGR, MCGR, AND VEPTR WITH AGE-MATCHED CONTROLS AND TO ASSESS URINE TITANIUM AND SERIAL SERUM TITANIUM LEVELS IN PATIENTS WITH EOS WITH GFI. : TWENTY PATIENTS WITH EOS (6 TGR, 8 MCGR, AND 6 VEPTR) AND 12 CONTROLS WERE ANALYZED. PATIENTS WITH EARLY ONSET SCOLIOSIS (EOS) TREATED WITH TRADITIONAL GROWING RODS (TGR), MAGNETICALLY CONTROLLED GROWING RODS (MCGR), AND VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: VEPTR (DEPUY SYNTHES, RAYNHAM, MA). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: VEPTR (QTY 1): 1 PATIENT HAD SURGICAL SITE INFECTIONS REQUIRED DEBRIDEMENT 5 YEARS AFTER HIS INDEX SURGERY. HE UNDERWENT 13 ADDITIONAL DEBRIDEMENTS FOR WOUND DRAINAGE OR EXPOSED IMPLANTS WITH DEEP TISSUE CULTURES POSITIVE FOR METHICILLIN SENSITIVE STAPHYLOCOCCUS AUREUS AND COAGULASE-NEGATIVE STAPHYLOCOCCUS AUREUS. HIS SERUM TITANIUM AT THE FIRST COLLECTION WAS 7 NG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2245955 UNK - CONSTRUCTS: VEPTR PROSTHESIS, RIB REPLACEMENT MDI SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention