PIVOX™ Oblique Lateral Spinal System 2140002Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169594234), received between Jan 22, 2018 and Jul 28, 2023 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (3 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2023Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT PREVIOUSLY IMPLANTED WITH PLATES AND SCREWS IN A 2 LEVEL OLIF FOR DEGENERATIVE DISC DISEASE AT L2/3 & L3/4. IT WAS REPORTED THAT THE SURGEON NOTICED THAT THE PLATES AND SCREWS HAD BACKED OUT OF THE VERTEBRAL BODIES DURING A FOLLOW UP APPOINTMENT WITH THE PATIENT. THE PATIENT HAD ONGOING BACK PAIN. THE SURGEON IS PLANNING POSTERIOR FIXATION AT THESE LEVELS. THE DATE OF INITIAL OPERATION WAS (B)(6) 2023. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: Pain

  MAUDE report 17411901 ↗
• InjuryJul 28, 2023Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT PREVIOUSLY IMPLANTED WITH PLATES AND SCREWS IN A 2 LEVEL OLIF FOR DEGENERATIVE DISC DISEASE AT L2/3 L3/4. IT WAS REPORTED THAT THE SURGEON NOTICED THAT THE PLATES AND SCREWS HAD BACKED OUT OF THE VERTEBRAL BODIES DURING A FOLLOW UP APPOINTMENT WITH THE PATIENT. THE PATIENT HAD ONGOING BACK PAIN. THE SURGEON IS PLANNING POSTERIOR FIXATION AT THESE LEVELS. THE DATE OF INITIAL OPERATION WAS (B)(6) 2023. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: Pain

  MAUDE report 17411890 ↗
• MalfunctionMar 16, 2021Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH OBLIQUE LATERAL INTERBODY FUSION THERAPY. IT WAS REPORTED THAT THE IMPLANT WAS PULL OUT. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11490639 ↗
• InjuryJan 22, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH NON UNION AND BROKEN RODS AT THIS LEVEL AND UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION. POST OP, THE PLATE SUBSIDED TO THE LEFT ABOUT 10-20 MM OFF THE BONE. AS A RESULT PAIN WAS OBSERVED IN THE PATIENT. FUSION WAS NOT ACHIEVED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 7208847 ↗