BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - PSI IMPLANTS: TRAUMA

    MDR report key: 24744618 · Received March 31, 2026

    Report

    Report Number
    8030965-2026-02980
    Event Type
    Injury
    Date Received
    March 31, 2026
    Date of Event
    January 25, 2026
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    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. H11 ADDITIONAL NARRATIVE: 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: VEDICHERLA SV, CHEW Z, CHIA ML, LEONG A, YAP YL, NGA VDW. APPLICATION OF A CUTTING GUIDE TO OPTIMIZE FIT OF 3D-PRINTED PATIENT-SPECIFIC IMPLANTS IN RECONSTRUCTION FOLLOWING RESECTION OF OSSEO-INVASIVE TUMORS. CUREUS. 2026 JAN 25;18(1):E102281. DOI: 10.7759/CUREUS.102281. PMID: 41755935; PMCID: PMC12933380. OBJECTIVE/METHODS/STUDY DATA: THIS STUDY AIMS TO REPORT THE USE OF A COMMERCIALLY AVAILABLE RESECTION TEMPLATE TO OPTIMIZE PATIENT-SPECIFIC IMPLANTS (PSI) FIT IN A SINGLE-STEP PROCEDURE, TO IMPROVE RESECTION AND RECONSTRUCTION OUTCOMES, AND PRESENT OUR INSTITUTIONAL EXPERIENCE WITH A CASE SERIES OF FIVE PATIENTS. THEY INCLUDE FIVE PATIENTS (FOUR MEN AND ONE WOMAN) WITH OSSEO-INVASIVE TUMORS WHO UNDERWENT SURGERY AT THEIR INSTITUTION FROM JUNE 2023 TO JANUARY 2025. THE RESECTION STRATEGY WAS PREPLANNED AND SHARED WITH THE MANUFACTURER (SYNTHES®,WEST CHESTER, PA, USA, AND PROTOMED®, WESTMINSTER, CO, USA, PSI), WHO PROVIDED THE PSI AND CUTTING TEMPLATE USED FOR RECONSTRUCTION. IN ALL CASES, THEY USED THE CUSTOM-MADE PEEK PROSTHESES, WITH STIFFNESS AND STRENGTH SIMILAR TO BONE (SYNTHES® AND PROTOMED® PSI). POSTOPERATIVE BRAIN MRI WAS PERFORMED TO ASSESS THE EXTENT OF TUMOR RESECTION AND CRANIOPLASTY FIT. WOUNDS WERE REVIEWED 10-14 DAYS POSTOPERATIVELY FOR SUTURE OR STAPLE REMOVAL IN THE CLINIC. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES PSI IMPLANT ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - PSI IMPLANTS (QTY 1): A 45-YEAR-OLD WOMAN EXPERIENCED SEIZURES THAT WERE CONTROLLED WITH ANTICONVULSANTS. SMALL REMNANTS OVER THE ANTERIOR AND POSTERIOR SUPERIOR SAGITTAL SINUS (SSS) INCREASED IN SIZE ON FOLLOW-UP AND WERE TREATED WITH GAMMA KNIFE SURGERY (GKS) 11 MONTHS POST-SURGERY (THREE DIFFERENT LESIONS MEASURING 5.7, 1.7, AND 0.5 CC). ALL LESIONS WERE TREATED WITH A PRESCRIPTION DOSE OF 13 GRAY (GY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800645 UNK - PSI IMPLANTS: TRAUMA PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention