PIVOX™ Oblique Lateral Spinal System 2140010Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00643169639522), received between Jul 14, 2017 and Jul 21, 2022 — classified as 4 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING OLIF DUE TO DEG ENRATIVE DISC DISEASE. IT WAS REPORTED THAT THE THREAD FROM THE INSERTER BROKE OFF IN THE THREAD OF THE IMPLANT. FRAGMENT OF INSERTER REMAINED INSIDE PATIENT. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15071788 ↗
• MalfunctionDec 16, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A PIVOX CAGE AND PLATE USING AN INSERTER IN AN L3/4 FUSION FOR AN UNKNOWN SPINAL INDICATION. IT WAS REPORTED THAT THE INSERTER TIP THREAD BROKE OFF WHILE INSERTING PIVOX CAGE AND PLATE. THE BROKEN TIP SUCCESSFULLY REMOVED AND PROCEDURE SUCCESSFULLY COMPLETED. THERE WAS NO ADVERSE EVENT TO PATIENT. NO ADDITIONAL SURGERY REQUIRED, ONLY A SHORT DELAY WHEN RETRIEVING THE BROKEN TIP. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13017010 ↗
• MalfunctionMar 2, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH UNKNOWN INDICATION INVOLVED IN SPINAL THERAPY. IT WAS REPORTED THAT DURING PROCEDURE, THE THREADS ON THE DRIVER BROKE OFF IN THE PIVOX CAGE. THEY WERE ABLE TO REMOVE THE BROKEN PIECE BY UNTHREADING IT WITH A PITUITARY. THE BROKEN INSTRUMENT DID NOT CAUSE ANY HARM TO THE PATIENT. THERE WAS A DELAY OF ABOUT 30 MINUTES. NO FRAGMENTS WERE LEFT IN THE PATIENT. THERE WERE NO PATIENT SYMPTOMS/ COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. PATIENT IS ALIVE AND NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11397637 ↗
• MalfunctionSep 28, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN INDICATION OF OSTEOPOROSIS, HYPERTENSION IN NEED OF OLIF L3/4 L4/5 USED IN SPINAL THERAPY. IT WAS REPORTED THAT THE ALL-IN-ONE INSERTER WAS USED WITH A SMALL PLATE AND CAGE ATTACHED, THE CAGE WAS IMPACTED AND WHEN THE DRIVER WAS LOOSENED TO BE ABLE TO ROTATE THE PLATE INTO POSITION AND IT WOULDN'T RETIGHTEN AND IT WAS THEN REALISED THE INSERTER TIP HAD BROKEN. THE SURGEON REMOVED THE HANDLE AND THEN HAD TO REMOVE THE BROKEN OFF TIP FROM THE PATIENT USING A PITUITARY RONGUER, THE CAGE WAS THEN READJUSTED USING THE STAND-ALONE INSERTER AND THE PLATE THEN INSERTED SEPARATELY. NO PATIENT HARM CAUSED, EXTRA TIME WAS TAKEN TO ADJUST THE CAGE AND REINSERT THE PLATE. THERE WAS A DELAY OF LESS THAN 60 MINS IN OVERALL PROCEDURE TIME REPORTED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FRAGMENTS IN THE PATIENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10591605 ↗
• MalfunctionSep 14, 2020Break; Mechanics Altered; Break; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING OBLIQUE LATERAL INTERBODY FUSION (OLIF) (LEVELS IMPLANTED -3/4) DUE TO DEGENERATIVE DISC DISEASE. IT WAS REPORTED THAT THE PIN AT THE END OF INSERTER THAT HOLDS THE PLATE IN PLACE BROKE WHILST IMPLANT WAS BEING IMPLANTED. THE PIN ENDED UP CONNECTING THE PLATE TO THE CAGE, AND THEREFORE BOTH WERE REMOVED AND A NEW PLATE AND CAGE IMPLANTED WITH THEIR RESPECTIVE INDIVIDUAL INSERTERS. THE INSTRUMENTS WERE EXPLANTED AND REPLACED. INSTRUMENTS WILL BE RETURNED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10527503 ↗
• MalfunctionSep 8, 2020Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA FIELD REPRESENTATIVE REGARDING INSTRUMENT INVOLVED IN OBLIQUE LATERAL INTERBODY FUSION (OLIF) PROCEDURE AT L2 AND L3. IT WAS REPORTED THAT DURING PROCEDURE, THREADED TIP BROKE OFF DURING PLACEMENT OF IMPLANT. REPORTED INSTRUMENT BROKE AND THEY WERE USED QUITE FREQUENTLY. THEY COMPLETED THE PROCEDURE WITH BACK UP SETS THAT WAS AVAILABLE. REPORTED, THEY WERE ABLE TO REMOVE THE TIP OUT OF THE INSTRUMENT WITH NEEDLE NOSE PLIERS. SO, THERE WERE NO FRAGMENTS LEFT IN THE PATIENT. THERE WAS DELAY IN PROCEDURE FOR ABOUT 30 MINUTES TOTAL. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. PATIENT IS ALIVE AND NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10502294 ↗
• MalfunctionAug 19, 2020Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT THAT OCCURRED DURING AN UNKNOWN SPINAL PROCEDURE. IT WAS REPORTED THAT THREADED SHAFT OF THE INSERTER BROKE OFF. PRODUCT WILL BE RETURNED, AND IT WILL BE REPLACED WITH A MEDTRONIC PRODUCT IN THE FUTURE. THE ENTIRE BROKEN PIECE WAS REMOVED FROM THE PATIENT AND THERE WAS NO HARM CAUSED TO THE PATIENT. NO OTHER PATIENT INJURY / COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10424066 ↗
• MalfunctionMar 27, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH L2-L3 DEGENERATIVE DISC AND FORAMINAL STENOSIS AT L2-L3. SHE UNDERWENT OBLIQUE LATERAL/DIRECT LATERAL INTERBODY FUSION AT L2-L3. INTRA-OP, THE CONNECTION BETWEEN INSERTER AND IMPLANT BROKE. NO FRAGMENT OF THE INSTRUMENT REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9887428 ↗
• MalfunctionJul 27, 2019Break; Break

  IT WAS REPORTED THAT INTRA-OP, WHEN THE SURGEON WENT TO DISENGAGE THE SET SCREW FROM THE PLATE, THE SCREW OF THE INSERTER BROKE OFF AND STUCK ON THE PLATE. THE BROKEN SCREW WAS REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8834442 ↗
• InjuryFeb 5, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION. INTRA-OP, THE INSERTER BROKE. THE DOCTOR ACKNOWLEDGED THAT IT WAS HIS FAULT BECAUSE HE LEVERED ON THE INSERTER MORE THAN THE NORMAL USE. THE BROKEN PIECE REMAINED INSIDE THE PATIENT. THE SURGEON FELT IT WAS UNNECESSARY TO REMOVE IT SINCE IT WAS CONTAINED WITHIN THE PLATE. SURGERY WAS COMPLETED SUCCESSFULLY WITH ONLY A SLIGHT DELAY OF LESS THAN 5 MINUTES. THERE WERE NO PATIENT COMPLICATIONS OR SYMPTOMS AS A RESULT OF THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8304974 ↗
• InjuryNov 13, 2017Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN OBLIQUE LUMBAR INTER-BODY FUSION SURGERY (OLIF) AT L3-L4. INTRA-OP, INSERTER'S SCREW AT THE TIP WAS BROKEN. THE BROKEN PIECE WAS STUCK INSIDE THE LOCKING CAP OF THE CAGE. SURGEON WAS UNABLE TO TWIST THE LOCKING CAP WITH THE SCREW DRIVER AS THE BROKEN PIECE WAS STUCK IN THE MIDDLE OF THE LOCKING CAP. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7026506 ↗
• InjuryAug 4, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT DIRECT LATERAL INTERBODY FUSION AT L2-5 USING STANDARD LATERAL APPROACH DUE TO SPINAL STENOSIS AND DEGENERATIVE DISC AT L2-5. DURING THE SURGERY, THE PIECE OF THE ALL-IN-ONE-INSERTER THAT THREADS INTO THE INTERBODY TO RETAIN IT TO THE INSERTER BROKE OFF IN THE IMPLANT. THE FRAGMENT COULD NOT BE REMOVED FROM THE INTERBODY. NO PATIENT COMPLICATIONS WERE REPORTED AS THE RESULT OF THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6766346 ↗
• InjuryJul 14, 2017Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2017, INTRA-OP, THE TIP OF THE INSERTER BROKE WHEN ALIGNING THE CAGE INTO ITS OPTIMUM POSITION. BECAUSE THE TIP HOLDS THE CAGE AND PLATE TOGETHER THE DOCTOR WAS UNABLE TO REMOVE FROM THE PATIENT AND WAS LEFT IN-SITU. THE INSERTER BROKE IN-SITU. THE PART OF THE INSTRUMENT BROKE OFF WHEN DOCTOR WAS UNABLE TO GET OUT AND OPTED TO LEAVE DUE TO SAFETY, THUS HE WAS UNABLE TO USE THE LOCKING MECHANISM ON THE PLATE TO LOCK THE SCREWS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6713381 ↗