PIVOX™ Oblique Lateral Spinal System 2161000Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00643169639591), received between Mar 16, 2018 and Dec 16, 2025 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT WHILE IMPLANTING A PIVOX CAGE DURING A SPINAL PROCEDURE, THERE WAS A BROKEN INSERTER TIP AND A BROKEN INNER SHAFT OF THE INSERTER. THE CAGE WAS APPROXIMATELY ONE-QUARTER OF THE WAY INSERTED AT A ROUGHLY 20-DEGREE ANGLE WHEN THE INSERTER TIP ON THE INNER SHAFT SNAPPED. THE CAGE WAS ABLE TO BE PULLED OUT, BUT THERE WERE NO OTHER INSERTION OPTIONS AVAILABLE, WHICH REQUIRED THE USE OF A COMPETITOR¿S OLIF CAGE AND INSERTER. THE COMPETITOR¿S INSERTER FUNCTIONED WITHOUT ISSUE. THIS SITUATION CAUSED A DELAY OF 10-15 MINUTES WHILE A COMPETITOR¿S SET WAS MOBILIZED. THE PATIENT EXPERIENCED A DELAY IN THE PROCEDURE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE DELAY WAS LESS THAN 60MINS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23814516 ↗
• MalfunctionFeb 11, 2025Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM THE USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE INSERTER TIP IS BENT. 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 21352606 ↗
• MalfunctionMay 24, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT FOR UNKNOWN SPINAL THE RAPY. IT WAS REPORTED THAT THE INSTRUMENT WOULD NOT STAY TIGHT ON THE IMPLANT. THE TREADED PORTION OF THE INSERTER BROKE WHILE MANIPULATING THE IMPLANT ACCORDING TO THE SURGICAL TECHNIQUE. NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT BOTH THE REPORTED INSTRUMENTS WERE BROKEN. THE OUTER INSERTER WOULD NOT STAY TIGHT, AND THE INNER THREADED INSERTER TIP BROKE. THE REPORTED PRODUCTS BROKE WHILE INSERTING THE IMPLANT INTO THE PATIENT. THERE ARE NO BROKEN FRAGMENTS IN THE PATIENT AND NO REVISION SURGERY IS PLANNED. THERE WAS NO MALFUNCTION OF THE IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14486941 ↗
• MalfunctionOct 21, 2021Break; Break

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP FOR A PATIENT UNDERGOING OLIF SPINAL PROCEDURE. IT WAS REPORTED THAT, THE INSERTER AND SHAFT TIP'S WERE BROKEN. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED. THERE WAS NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12671092 ↗
• MalfunctionAug 16, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION (OLIF) AT L2-5 DUE TO DEGEN DEFORMITY. INTRA-OP, THE INSERTER BROKE WHEN TRYING TO LEVERAGE THE INTER-BODY INTO THE DISC SPACE. NO FRAGMENTS OF THE BROKEN INSTRUMENT REMAINED IN THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8901535 ↗
• MalfunctionAug 16, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION (OLIF) AT L2-5 DUE TO DEGEN DEFORMITY. INTRA-OP, THE INSERTER BROKE WHEN TRYING TO LEVERAGE THE INTER-BODY INTO THE DISC SPACE. NO FRAGMENTS OF THE BROKEN INSTRUMENT REMAINED IN THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8901508 ↗
• MalfunctionApr 26, 2019Break; Break

  IT WAS REPORTED THAT INTRA-OP, THE TIP OF THE INSERTER BROKE WHEN INSERTING THE IMPLANT. NO PATIENT SYMPTOMS OR COMPLICATION WERE REPORTED AS RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8554187 ↗
• InjuryMar 30, 2018Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNSPECIFIED SURGERY. INTRA-OP, TIP OF THE INSERTER WAS EXTREMELY WORN DOWN, ALMOST FLAT AND BROKE. IT WAS NOTICED THAT A PIECE OF THE TIP WAS MISSING AND REMAINED IN THE IMPLANT. IT COULD NOT BE RETRIEVED. NO PATIENT COMPLICATION WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7385225 ↗
• MalfunctionMar 16, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNSPECIFIED SPINAL SURGERY. INTRA-OP, THREADED SHAFT BROKE OFF AT THE TIP OF THE INSERTER WHILE SURGEON WAS INSERTING THE IMPLANT. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT OF THE IMPLANT REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7345052 ↗