N/A 2986055Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994236531), received between Mar 21, 2020 and Mar 21, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Malposition of Device” (1 report).

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 18, 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.

• InjuryMar 21, 2020Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH DEGENERATIVE KYPHOSIS; AND UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION AT L4-L5. INTRA-OP, AFTER TRIAL WAS INSERTED, BLEEDING AMOUNT INCREASED. BY CHECKING SAGITTAL IMAGE, IT WAS FOUND THAT THE POSITION OF THE TRIAL WAS ON THE ANTERIOR SIDE VERY MUCH. HEMOSTASIS WAS PERFORMED USING FLOSEAL AND AVITENE. THE CAGE INSERTION WAS COMPLETED WHILE PERFORMING HEMOSTASIS CAREFULLY. THE BLEEDING AMOUNT WAS ABOUT 1800CC. THE CAUSE OF THE BLEEDING COULD NOT BE IDENTIFIED, BUT IT WAS CONSIDERED THAT THERE WAS ALSO A POSSIBILITY THAT BLEEDING OCCURRED DURING THE REMOVAL OF THE INTERVERTEBRAL DISC OR DURING DEALING WITH THE VERTEBRAL ENDPLATE. ACCORDING TO THE DOCTOR, EXTERNAL ILIAC VEINS MAY HAVE RUPTURED. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN THE OVERALL PROCEDURE TIME. IT WAS UNKNOWN HOW MUCH THE PATIENT ISSUE WAS RESOLVED; BUT A POSTERIOR OPERATION FROM T10-S2 WAS SCHEDULED FOR (B)(6) 2020. ON (B)(6) 2020, A TWO-STAGE SURGERY, POSTERIOR FIXATION AT T9-S2 WAS PERFORMED. POSTERIOR LUMBAR INTERBODY FUSION WAS PERFORMED AT L5/S1 AND OSTEOTOMY WAS PERFORMED AT L3. PLIF AT L5-S1 WAS PERFORMED, FOLLOWED BY SCREW INSERTION, FOLLOWED BY OSTEOTOMY AT

  Patient problems: Blood Loss

  MAUDE report 9863432 ↗