PIVOX™ Oblique Lateral Spinal System 2140135Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169634770), received between Dec 1, 2020 and Aug 4, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 5 most recent of 5 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 L3/4. LEVELS IMPLANTED WAS L2/3 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 17457610 ↗
• InjuryJul 28, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A POSTERIOR FIXATION AND DECOMPRESSION OF L2-L4 WAS PERFORMED ON (B)(6) 2023.

  Patient problems: Pain

  MAUDE report 17411933 ↗
• InjuryJul 28, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  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 17411926 ↗
• InjuryJul 28, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  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 17411907 ↗
• InjuryDec 1, 2020Expulsion; Expulsion

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PLATE AND SCREW IMPLANTED IN A PATIENT USING PIVOX SURGERY. IT WAS REPORTED THAT AFTER SURGERY, THE SCREW TITANIUM PLATE WAS EXITED FROM THE VERTEBRAL BODY. NO OTHER PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED. THE PATIENT HAD UNDERGONE REVISION SURGERY ON NOVEMBER 12. THE PATIENT ISSUE IS TEMPORARILY RESOLVED. THE PRODUCT HAS NOT BEEN EXPLANTED YET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10926162 ↗