PIVOX™ Oblique Lateral Spinal System 2140140Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169634787), received between Jan 22, 2018 and Aug 4, 2023 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (2 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.

• InjuryAug 4, 2023Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT USED IN OBLIQUE LATERAL INTERBODY FUSION (OLIF) THERAPY FOR DEGENERATIVE DISC DISEASE L2/3 AND L3/4. LEVELS IMPLANTED WAS L2/3 AND L3/4. IT WAS REPORTED THAT THE SURGEON NOTICED THAT PLATES AND SCREWS HAD BACKED OUT OF THE VERTEBRAL BODIES. NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE SURGEON HAS PLAN TO REMOVE THE PLATES AND SCREWS AND A POSTERIOR FIXATION AT THESE LEVELS BUT NO OPERATION SCHEDULED YET. THE PATIENT IS EXPERIENCING PAIN.

  Patient problems: Pain

  MAUDE report 17457572 ↗
• MalfunctionMar 16, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  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 11490629 ↗
• 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 SCREW 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 7208849 ↗
• 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 SCREW 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 7208848 ↗