PIVOX™ Oblique Lateral Spinal System 2140130Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00643169634763), received between Oct 13, 2017 and Aug 4, 2023 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (7 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 8 most recent of 8 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 17457562 ↗
• InjuryDec 24, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGERY AT L4-S1 USING PLATES, SCREWS AND CAGES. ON AN UNKNOWN DATE, POST-OP, THE IMPLANTED SCREW LOOSENED AND CAME OUT OF ITS POSITION, ALLEGEDLY DUE TO LOADING FROM THE VERTEBRAL BODY. A REVISION SURGERY WAS PLANNED TO BE PERFORMED ON (B)(6) 2019 FOR REMOVING THE ALLEGED IMPLANT; HOWEVER, THE IMPLANT HAS NOT BEEN REMOVED YET. NO INFORMATION IS AVAILABLE IF THE PATIENT HAS UNDERGONE ANY REVISION SURGERY OR NOT. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9516841 ↗
• InjuryDec 24, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGERY AT L4-S1 USING PLATES, SCREWS AND CAGES. ON AN UNKNOWN DATE, POST-OP, THE IMPLANTED SCREW LOOSENED AND CAME OUT OF ITS POSITION, ALLEGEDLY DUE TO LOADING FROM THE VERTEBRAL BODY. A REVISION SURGERY WAS PLANNED TO BE PERFORMED ON (B)(6) 2019 FOR REMOVING THE ALLEGED IMPLANT; HOWEVER, THE IMPLANT HAS NOT BEEN REMOVED YET. NO INFORMATION IS AVAILABLE IF THE PATIENT HAS UNDERGONE ANY REVISION SURGERY OR NOT. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9516825 ↗
• InjuryDec 24, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGERY AT L4-S1 USING PLATES, SCREWS AND CAGES. ON AN UNKNOWN DATE, POST-OP, THE IMPLANTED SCREW LOOSENED AND CAME OUT OF ITS POSITION, ALLEGEDLY DUE TO LOADING FROM THE VERTEBRAL BODY. A REVISION SURGERY WAS PLANNED TO BE PERFORMED ON (B)(6) 2019 FOR REMOVING THE ALLEGED IMPLANT; HOWEVER, THE IMPLANT HAS NOT BEEN REMOVED YET. NO INFORMATION IS AVAILABLE IF THE PATIENT HAS UNDERGONE ANY REVISION SURGERY OR NOT. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9516819 ↗
• InjuryDec 24, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  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 9516754 ↗
• MalfunctionNov 28, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION(OLIF) AT S1. POST-OPERATIVELY, THE SCREW PULLED OUT. THE SURGEON PLACED THE SCREW ANTERIORLY INTO THE S1 VERTEBRAL BODY DURING THE OLIF PROCEDURE. DUE TO POOR BONE QUALITY, THE SCREW PULLED OUT AND WAS NOTICED THE NEXT DAY DURING A POSTERIOR PROCEDURE FOR PEDICLE SCREW FIXATION. THE SCREW STILL REMAINS IN SERVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7062469 ↗
• 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 SCREW HAS BACKED OFF THE VERTEBRAL BODY WITH THE SCREW STILL LOCKED INTO THE PLATE. PATIENT HAS PAIN AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 6947228 ↗
• 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 SCREW HAS BACKED OFF THE VERTEBRAL BODY WITH THE SCREW STILL LOCKED INTO THE PLATE. PATIENT HAS PAIN AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 6947225 ↗