PIVOX™ Oblique Lateral Spinal System 2112355Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169605213), received between Nov 18, 2016 and Nov 18, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2016Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT PATIENT UNDERWENT AN ANTERIOR/POSTERIOR RECONSTRUCTION (BILATERAL L4-5 ANTERIOR/POSTERIOR FUSION/OLIF) FOR GRADE II L4-L5 SPONDYLOLISTHESIS AND STENOSIS WITH INTERBODY CAGE, BMP AND AUTOGRAFT. FOLLOWING SURGERY THE PATIENT HAD A SIGNIFICANT AMOUNT OF PAIN AND UNDERWENT WORKUP THAT REVEALED WHAT APPEARED TO BE AN ACUTE SUPERIOR ENDPLATE FRACTURE AT THE LEVEL OF SURGERY (L5).A MECHANICAL ADVERSE EVENT OF IMBALANCE WAS NOTED AS ANTERIOR SUBLUXATION OF INDWELLING INTERBODY DEVICE (L4-5 DISC SPACE). THE PATIENT WAS TO START TREATMENT WITH ¿FORTEO¿. AT HER 6 WEEK POST-OP VISIT SHE WAS COMPLAINING OF LOW BACK PAIN AND WAS ON DILAUDID AND WAS WALKING WITH A ANTALGIC GAIT AND AMBULATING WITH A WALKER. DEXA DONE ON (B)(6) 2016 SHOWED MINERAL DENSITIES IN THE LOW-NORMAL RANGE WITH THE FEMORAL NECK BEING IN THE OSTEOPENIC RANGE. THE PATIENT WAS ALSO NOTED TO HAVE NEUROPATHY BOTH HANDS, DILAUDID WAS DECREASED IN STRENGTH AND DOSING AT THIS VISIT. AND PATIENT WAS CONTINUED ON BEDREST/DECREASED ACTIVITY. THE OUTCOME OF THIS EVENT IS CONSIDERED NOT RESOLVED.

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Neuropathy; Pain

  MAUDE report 6112000 ↗