NA 388.410Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034772868), received between Jul 11, 2022 and Jul 11, 2022 — classified as 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: LINHART, C. ET AL (2022), JUMPER¿S FRACTURE OF THE SACRUM: A NOVEL AND REPRODUCIBLE WAY FOR SUCCESSFUL REDUCTION AND FIXATION, EUROPEAN SPINE JOURNAL, VOL. 31 (XX), PAGES 18¿27 (GERMANY). THE AIM OF THIS OBSERVATIONAL RETROSPECTIVE STUDY TO DESCRIBE A TECHNIQUE WHERE REDUCTION IS POSSIBLE THROUGH COMBINATION OF RESTORING LENGTH VIA ROD DISTRACTION AND LORDOSIS BY USING A HINGE MECHANISM BETWEEN THE LONGITUDINAL RODS AND A HORIZONTAL ROD BETWEEN BOTH POSTERIOR SUPERIOR ILIAC PROCESSES. BETWEEN JANUARY 2015 AND DECEMBER 2019, A TOTAL OF 24 PATIENTS (17 MALE AND 7 FEMALE) WITH AN AVERAGE AGE 47 ± 16.3 YEARS WHO UNDERWENT ILIOLUMBAR STABILIZATION OF A JUMPER'S FRACTURE OF THE SACRUM WERE INCLUDED. THE TECHNIQUE IS BASED ON ONE OF THE MOST FREQUENTLY USED IMPLANTS FOR THE SPINE, THE UNIVERSAL SPINE SYSTEM (USSII) FROM DEPUY SYNTHES, WHICH MAKES IT HIGHLY REPRODUCIBLE FOR INTERESTED SURGEONS. THUS, REDUCTION IS PERFORMED VIA ITS SPECIFIC SURGICAL INSTRUMENTS, NAMELY THE DISTRACTION FORCEPS WHICH IS USED TO RESTORE LONGITUDINAL LENGTH BETWEEN THE PEDICLE SCREWS OF L4 AND L5, AND THE ¿USSII PERSUADER¿, WHICH IS U

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14978101 ↗