PIVOX™ Oblique Lateral Spinal System 2141000Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169639560), received between Mar 14, 2023 and Mar 11, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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.

• MalfunctionMar 11, 2026Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT. IT WAS REPORTED THAT AFTER PIVOX PLATE WAS IMPLANTED THE INSERTER WAS DAMAGED WHILE REMOVING. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24567612 ↗
• MalfunctionOct 16, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE INSERTER WAS BROKEN DURING WASH. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23308160 ↗
• MalfunctionNov 15, 2023Break; Mechanics Altered; Break; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT IS USED IN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE WASHER IN THE FLEX ARM IS BROKEN AND PIVOX PLATE INSERTER WILL NO LONGER HOLD PLATES. THERE IS NO PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18138455 ↗
• MalfunctionApr 17, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING OLIF T10-T12 WITH A REVISION PLF T6-L4 FOR DEGENERATIVE DISC DISEASE T10-T12. IT WAS REPORTED THAT THE INSERTER BROKE WHILE THE SURGEON WAS IMPLANTING A PIVOX PLATE, THE PLATE WAS INSERTED SUCCESSFULLY, AND THE BROKEN FRAGMENTS OF THE INSTRUMENT WERE RETRIEVED. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16751269 ↗
• MalfunctionMar 14, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT WHICH IS USED IN DIRECT LATERAL INTERBODY FUSION (DLIF) SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE WAS BROKEN. THERE WERE NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT AND NO FURTHER COMPLICATIONS OR S YMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16535297 ↗