BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SYNFLATE/VBS

    MDR report key: 19660411 · Received July 2, 2024

    Report

    Report Number
    8030965-2024-08226
    Event Type
    Injury
    Date Received
    July 2, 2024
    Date of Event
    January 30, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    NDN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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. ADDITIONAL NARRATIVE: D1, D2, D3, D4, G4 - 510K: THIS REPORT IS FOR AN UNKNOWN SYNFLATE/VBS/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H4, H6: WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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: OSWALD KAC, KÄLIN J, TINNER C, DEML MC, BIGDON SF, HOPPE S, BENNEKER LM, ALBERS CE. ANTERIOR THORACOLUMBAR COLUMN RECONSTRUCTION WITH THE VERTEBRAL BODY STENT-SAFETY AND EFFICACY. EUR SPINE J. 2023 MAR;32(3):934-949. DOI: 10.1007/S00586-023-07537-3. EPUB 2023 JAN 30. PMID: 36715755. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS STUDY WAS TO ASSESS SAFETY AND EFFICACY OF VERTEBRAL BODY STENTING BY ANALYZING (1) RADIOGRAPHIC OUTCOME, (2) CLINICAL OUTCOME, AND (3) PERIOPERATIVE COMPLICATIONS IN PATIENTS WITH VERTEBRAL COMPRESSION FRACTURES TREATED WITH VBS AT MINIMUM 6-MONTH FOLLOW-UP. IN TOTAL, 78 PATIENTS (MEAN AGE, 61±14 [21¿90] YEARS; 66.7% FEMALE) WITH 80 PAIRS OF VERTEBRAL BODY STENTS (=160 VBS TOTAL) WERE INCLUDED. OF THOSE, 57 PATIENTS (73%) RECEIVED ADDITIONAL POSTERIOR INSTRUMENTATION (52 =PERCUTANEOUS INSTRUMENTATION, 5=OPEN INSTRUMENTATION,) ONE VERTEBRA ABOVE AND ONE VERTEBRA BELOW THE FRACTURED VERTEBRA. ALL PROCEDURES WERE PERFORMED UNDER GENERAL ANESTHESIA AND ACCORDING TO THE SURGICAL GUIDELINE FOR VERTEBRAL BODY STENTING BY DEPUY SYNTHES. PATIENTS WERE PLACED IN PRONE POSITION ON A RADIOLUCENT TABLE. ACCESS KIT 4.7 (DEPUY SYNTHES SPINE, INC., RAYNHAM, MA, USA) WAS UTILIZED FOR TRANSPEDICULAR ACCESS. UNDER FLUOROSCOPIC GUIDANCE, POLYMETHYLMETHACRYLATE (PMMA) CEMENT (VERTECEM V +, DEPUY SYNTHES, RAYNHAM, MA, USA) WAS INJECTED BILATERALLY INTO THE STENT CAVITIES UNTIL THE STENTS WERE COMPLETELY FILLED WITH SOME CEMENT OUTSIDE THE STENT INTERDIGITATING WITH THE SURROUNDING BONE. RADIOGRAPHIC AND CLINICAL OUTCOME WAS ANALYZED DIRECTLY, 6 WEEKS, 12 WEEKS, 6 MONTHS POSTOPERATIVELY, AND AT LAST FOLLOW-UP. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - SYNFLATE/VBS: SYNFLATE. (QTY 9) 4 PATIENTS HAD MATERIAL FAILURE (INSUFFICIENT BALLOONING) WITH NO INTERVENTION REPORTED. 3 PATIENTS HAD VBS DISLOCATION OR CUT OUT WITH NO INTERVENTION REPORTED. 1 PATIENT HAD ADJACENT SEGMENT FRACTURE WITH NO INTERVENTION REPORTED. 1 PATIENT HAD REVISION SURGERY. THE PATIENT SUFFERED FROM MULTIPLE HEMATOGENIC INFECTIONS WITH STREPTOCOCCUS MITIS, STAPHYLOCOCCUS AURES AND SERRATIO MARCENSENS AT THE TIME POINT OF THE INITIAL TRAUMA AND INDEX SURGERY. FIVE MONTHS AFTER INDEX SURGERY, HE DEVELOPED POTENTIAL PROCEDURE RELATED SPONDYLODISCITIS WITH SUBSEQUENT BONE NECROSIS AT THE VBS LEVEL. THEREFORE, A SUBTOTAL CORPORECTOMY WITH CAGE REPLACEMENT, DISC BIOPSY AND POSTERIOR INSTRUMENTATION WAS PERFORMED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - BIOMATERIAL - CEMENT: VERTECEM V+ (QTY 34) 33 PATIENTS HAD CEMENT LEAKAGE. CEMENT LEAKAGE INTO THE ANTEROLATERAL, PARAVERTEBRAL REGION WAS PRESENT IN 21 PATIENTS, INTRADISCAL CEMENT LEAKAGE IN ELEVEN PATIENTS AND POSTERIOR CEMENT LEAKAGE INTO THE SPINAL CANAL IN ONE PATIENT. NONE OF THE CEMENT LEAKAGES HAD A CLINICALLY RELEVANT CONSEQUENCE REQUIRING FURTHER TREATMENT. 1 PATIENT HAD REVISION SURGERY. THE PATIENT SUFFERED FROM MULTIPLE HEMATOGENIC INFECTIONS WITH STREPTOCOCCUS MITIS, STAPHYLOCOCCUS AURES AND SERRATIO MARCENSENS AT THE TIME POINT OF THE INITIAL TRAUMA AND INDEX SURGERY. FIVE MONTHS AFTER INDEX SURGERY, HE DEVELOPED POTENTIAL PROCEDURE RELATED SPONDYLODISCITIS WITH SUBSEQUENT BONE NECROSIS AT THE VBS LEVEL. THEREFORE, A SUBTOTAL CORPORECTOMY WITH CAGE REPLACEMENT, DISC BIOPSY AND POSTERIOR INSTRUMENTATION WAS PERFORMED. THIS REPORT IS FOR UNKNOWN SYNFLATE/VBS. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755823 UNK - SYNFLATE/VBS CEMENT, BONE, VERTEBROPLASTY NDN SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention