BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 24978127 · Received April 24, 2026

    Report

    Report Number
    3003120897-2026-00768
    Event Type
    Injury
    Date Received
    April 24, 2026
    Date of Event
    August 23, 2025
    Report Date
    April 24, 2026
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    OWI
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2: MEDIAN PATIENT AGE AT SURGERY WAS 9 YEARS A.3B. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. B.3. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. D1, D.4. PRODUCT IDENTIFIERS ARE UNKNOWN. G4. PMA / 510(K) #- UNKNOWN AS PRODUCT IDENTIFIERS ARE UNKNOWN H6: NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. CITATION: STANDARDIZED TRANSLAMINAR SPINAL TETHERING TO PREVENT PROXIMAL JUNCTIONAL KYPHOSIS IN ADULT SPINAL DEFORMITY CORRECTION SURGERY. TARIK ALP SARGUT, AHMAD ALMAHOZI, EMMANOUIL VERIGOS, LUCIUS FEKONJA, JOAN ALSOLIVANY, DIMITRI TKATSCHENKO, ANTON FRUH, SIMON BAYERL, NILS HECHT, PETER VAJKOCZY. EUROPEAN SPINE JOURNAL (2026) 35:187¿194. DOI: HTTPS://DOI.ORG/10.1007/S00586-025-09267-0. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING: STANDARDIZED PROXIMAL TRANSLAMINAR SPINAL TETHERING TO PREVENT PROXIMAL JUNCTIONAL KYPHOSIS (PJK) IN ADULT SPINAL DEFORMITY CORRECTION SURGERY. DEVICE INFORMATION: THE PUBLICATION REPORTS USE OF MULTIPLE MANUFACTURERS¿ SPINAL IMPLANTS. MEDTRONIC DEVICES IDENTIFIED IN THE STUDY INCLUDE: TRANSLACE¿ M POLYESTER TETHER, ROD CONNECTORS ADVERSE EVENTS / DEVICE PERFORMANCE: ADVERSE EVENTS REPORTED IN THE STUDY POPULATION INCLUDED PROXIMAL JUNCTIONAL KYPHOSIS (PJK). REVISION SURGERY FOR PJK WAS REPORTED AS 4 PATIENTS IN NON-TETHERED AND 1 IN TETHERED PATIENTS. THE PUBLICATION DOES NOT DESCRIBE ANY MEDTRONIC DEVICE SPECIFIC MALFUNCTIONS, FAILURES, OR PERFORMANCE RELATED COMPLAINTS. CONCLUSION: BASED ON THE INFORMATION PROVIDED IN THE PUBLICATION, NO NEW OR UNEXPECTED SAFETY SIGNALS RELATED TO MEDTRONIC DEVICES WERE IDENTIFIED. NO ADDITIONAL INFORMATION PERTAINING SPECIFICALLY TO MEDTRONIC PRODUCT PERFORMANCE OR SAFETY WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1038563 UNKNOWN BONE FIXATION CERCLAGE, SUBLAMINAR OWI MEDTRONIC SOFAMOR DANEK USA, INC. MSB_UNK_UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Unknown Required Intervention