BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - BIOMATERIAL - PREFORMED: CHRONOS: SPINE

    MDR report key: 24377349 · Received February 18, 2026

    Report

    Report Number
    8030965-2026-01601
    Event Type
    Injury
    Date Received
    February 18, 2026
    Date of Event
    May 6, 2010
    Manufacturer
    SYNTHES GMBH
    Product Code
    LOD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11 ADDITIONAL NARRATIVE: ADDED: D4 CATALOG. 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #(B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: SCHIMMEL JJ, HORSTING PP, DE KLEUVER M, WONDERS G, VAN LIMBEEK J. RISK FACTORS FOR DEEP SURGICAL SITE INFECTIONS AFTER SPINAL FUSION. EUR SPINE J. 2010 OCT;19(10):1711-9. DOI: 10.1007/S00586-010-1421-Y. EPUB 2010 MAY 6. PMID: 20445999; PMCID: PMC2989231. OBJECTIVE/METHODS/STUDY DATA: THE PURPOSE OF THIS STUDY IS TO COMPARE PATIENTS WHO DEVELOPED DEEP SURGICAL SITE INFECTIONS (SSI) FOLLOWING LUMBAR OR THORACOLUMBAR SPINAL FUSION WITH A RANDOMLY SELECTED GROUP OF PATIENTS WHO DID NOT DEVELOP THIS COMPLICATION IN ORDER TO IDENTIFY CHANGEABLE RISK FACTORS. BETWEEN JANUARY 1999 AND DECEMBER 2008, PATIENTS WHO UNDERWENT SPINAL FUSIONS WERE REVIEWED. DURING THIS PERIOD, 1,615 LUMBAR FUSIONS IN 1,568 PATIENTS WERE PERFORMED. ALL TYPES OF DIAGNOSES WERE CONSIDERED IN THE ANALYSIS. THE TYPE OF OPERATIVE PROCEDURE WAS CLASSIFIED AS HAVING ONE POSTERIOR PROCEDURE, A COMBINED POSTERIOR/ANTERIOR PROCEDURE WITH THE PATIENT UNDER THE SAME ANAESTHESIA OR A TWO-STAGES POSTERIOR/ANTERIOR PROCEDURE PERFORMED ON SEPARATE DAYS. IN ALL PATIENTS WHO UNDERWENT A TWO-STAGED PROCEDURE ON SEPARATE DAYS, ONLY THE FIRST (POSTERIOR) PROCEDURE WAS SELECTED FOR THE SUBSEQUENT ANALYSES. THE SECOND (ANTERIOR) PROCEDURE WAS PERFORMED 7 DAYS AFTER THE FIRST SURGERY, AND IF POSSIBLE, PATIENTS WERE MOBILIZED AND DISCHARGED BETWEEN THE TWO SURGERIES. THE USE OF BONE GRAFT WAS SCORED AS AUTOGRAFT OR ALLOGRAFT. IF BOTH AUTOGRAFT AND ALLOGRAFT WERE USED, WE SCORED THIS AS ALLOGRAFT. WE SCORED AUTOGRAFT IF BONE WAS USED IN COMBINATION WITH CHRONOS¿ (B-TRICALCIUM PHOSPHATE BONE GRAFT SUBSTITUTE, SYNTHES) WHICH WAS USED IN 121 CASES (TABLE 4). A TOTAL OF 36 CASES WITH DEEP SSI WERE IDENTIFIED AND CONFIRMED THROUGH MICROBIOLOGICAL CULTURES. WITH THE USE OF A RANDOM NUMBER GENERATOR, 135 CONTROL PATIENTS WITHOUT SSI WERE SELECTED FROM THE COHORT OF PATIENTS WHO UNDERWENT A SPINAL FUSION IN THE SPECIFIED PERIOD. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES CHRONOS¿. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - BIOMATERIAL - PREFORMED: CHRONOS: SPINE (QTY 1): A PATIENT (30 YEARS AT SURGERY) IN WHOM INITIAL SURGERY CONSISTED OF A COMBINED POSTERIOR/ANTERIOR PROCEDURE ON THE SAME DAY, WITH THE USE OF AUTOGRAFT AND IMPLANTED INSTRUMENTATION, HAD INFECTED WITH E. COLI AND HAD A TOTAL OF SEVEN REPEATED SURGERIES IN A PERIOD OF 18 MONTHS. IN THE 4-MONTH PERIOD AFTER THE INITIAL OPERATION FOUR SURGERIES WITH DEBRIDEMENTS AND GENTAMYCIN BEADS WERE PERFORMED. THREE MONTHS LATER THE GENTAMYCIN BEADS WERE REMOVED AND THE TRANSLAMINAR SCREWS WERE TIGHTENED. SEVENTEEN MONTHS AFTER THE INITIAL SURGERY A SOLID FUSION WAS ACHIEVED, AND THE TWO TRANSLAMINAR SCREWS WERE REMOVED, BUT TWO CHAINS OF GENTAMYCIN BEADS WERE PLACED TO TREAT A DORSAL FISTULA. AFTER A WEEK, A FINAL SURGERY WAS NECESSARY TO REMOVE THOSE GENTAMYCIN BEADS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - BIOMATERIAL - PREFORMED: CHRONOS: SPINE (QTY 16): (N=16) HAD DEEP SURGICAL SITE INFECTIONS. ALL PATIENTS UNDERWENT AT LEAST ONE REOPERATION TO TREAT THE INFECTION, INCLUDING AN OPEN DEBRIDEMENT AND RECEIVED APPROPRIATE ANTIBIOTICS TO TREAT THE ORGANISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491606 UNK - BIOMATERIAL - PREFORMED: CHRONOS: SPINE BONE CEMENT LOD SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention