PIVOX™ Oblique Lateral Spinal System 2140001Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169594227), received between Oct 13, 2017 and Aug 4, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Mechanical Problem” (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 6 most recent of 6 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 L ATERAL 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 17457540 ↗
• InjuryAug 4, 2023Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT USED IN OBLIQUE L ATERAL 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 17457520 ↗
• 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 10926158 ↗
• InjuryDec 24, 2019Mechanical Problem; Mechanical Problem

  THE REVISION WAS PLANNED BUT THE PATIENT WAS NOT DOING WELL DUE TO HIS OTHER PREVIOUS ILLNESS AND HIS OLD AGE. THE PATIENT RECEIVED DORSAL STABILIZATION. HENCE, THE IMPLANT STILL REMAINS IMPLANTED IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9516727 ↗
• InjuryDec 24, 2019Mechanical Problem; Mechanical Problem

  THE REVISION WAS PLANNED BUT THE PATIENT WAS NOT DOING WELL DUE TO HIS OTHER PREVIOUS ILLNESS AND HIS OLD AGE. THE PATIENT RECEIVED DORSAL STABILIZATION. HENCE, THE IMPLANT STILL REMAINS IMPLANTED IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9516671 ↗
• InjuryOct 13, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT PATIENT UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION (OLIF) AT L3-L4. POST-OP, THE PLATE HAS BACKED OFF THE VERTEBRAL BODY. PATIENT HAS PAIN AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 6947226 ↗