Medtronic Reusable Instruments 2986845Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994352385), received between Sep 19, 2017 and Dec 5, 2017 — classified as 2 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 5, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION (OLIF) DUE TO LUMBAR DEGENERATIVE SCOLIOSIS. DURING THE SURGERY, BLEEDING OCCURRED SUDDENLY AFTER TRIAL INSERTION. AFTER THE FIXATION OF L1/5 AND PLACING THE CAGE AT L1/2, A TRIAL WAS INSERTED TO L2/3, SURGEON INSTALLED IT SLIGHTLY FORWARD AND THEN WHEN IT WAS PULLED OUT, BLEEDING STARTED. ABOUT 500 CC BLEEDING WAS OBSERVED IN 2-3 MINUTES. THE SURGEON CONDUCTED HEMOSTASIS USING FLOSEAL, AND INSERTED AN IMPLANT. HOWEVER THE SURGEON COULD NOT INSERT IT IN PROPER POSITION, SO THE IMPLANT WAS REMOVED AS IT WAS INSTALLED IN ANTERIOR DIRECTION. HEMOSTASIS WAS CONDUCTED AGAIN, AND THEN ONE SIZE SHORTER IMPLANT WAS PLACED. THE BLEEDING WAS CHECKED BEFORE CLOSING THE INCISION, BUT IT WAS NOT OBSERVED, SO THE SURGERY WAS FINISHED. IT IS UNKNOWN WHETHER THE BLEEDING CAME FROM, BLOOD VESSELS OR INTERVERTEBRAL BODIES. THERE WAS A DELAY OF LESS THAN 60 MINUTES AS A RESULT OF THIS EVENT.

  Patient problems: Blood Loss

  MAUDE report 7081869 ↗
• InjurySep 19, 2017Use of Device Problem; Use of Device Problem

  PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: LUMBAR DEGENERATIVE SCOLIOSIS PROCEDURE USED: OBLIQUE LUMBAR INTERBODY FUSION (OLIF) IT WAS REPORTED THAT INTRA-OP, THE TRIAL WAS MISS-INTRODUCED INTO THE SPINAL CANAL DURING MANIPULATION. THE DELAY IN PROCEDURE TIME WAS LESS THAN 60MIN. POST-OP, PATIENT WAS SUSPECTED TO HAVE SUFFERED WITH BILATERAL PARALYSIS. PRODUCT DID NOT MALFUNCTION IN ANY WAY. NO REVISION WAS SCHEDULED.

  Patient problems: Paralysis; Spinal Cord Injury

  MAUDE report 6875008 ↗