PIVOX™ Oblique Lateral Spinal System 2161001Recalls & reported problems

Summary

The FDA's MAUDE database contains 182 adverse event reports that list this exact device (DI 00643169639607), received between Jun 14, 2017 and Jan 2, 2024 — classified as 11 injuries, 171 malfunctions.

The most frequently reported specific device problem is “Break” (176 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 25 most recent of 182 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING U NKNOWN SPINAL PROCEDURE. IT WAS REPORTED THAT THIS INSERTER TIP SHEARED OFF WHEN WE IMPLANTED A PIVOX CAGE. THE SHEARED OFF PORTION REMAINS THREADED INTO THE CAGE THAT IS IMPLANTED IN THE PATIENT. THE SURGEON HAS NO PLANS TO REVISE BECAUSE THERE IS NO WAY TO REATTACH TO THE IMPLANT SINCE THE INSERTER TIP IS THREADED INTO THE IMPLANT HOLDER. THIS INSTRUMENT WAS NOT USED DURING THE SURGERY, BECAUSE WE LOOKED AND SAW THE INSTRUMENT TIP WAS CHIPPED AND DIDN'T WANT TO USE IT. 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 18424013 ↗
• MalfunctionAug 29, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT WILL BE USED IN OBLIQUE LATERAL INTERBODY FUSION (OLIF) AT L4/5 PROCEDURE FOR DEGENERATIVE SPONDYLOSIS WITH SPINAL STENOSIS. LEVELS IMPLANTED WAS L4-5. IT WAS REPORTED THAT UPON INSERTION OF THE PIVOX CAGE AT THE L4-5 DISC SPACE, THE TIP OF THE THE PIVOX INSERTER SHAFT BROKE OFF DURING IMPACTION AND LEFT INSIDE THE PATIENT. NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE IS NO ADDITIONAL SURGERY PLANNED FOR THE REMOVAL OF BROKEN FRAGMENTS. THERE IS CURRENTLY NO MALFUNCTION WITH THE CAGE AND IT IS STILL IMPLANTED IN PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17640573 ↗
• MalfunctionJun 16, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A PIVOX IMPLANT USING A SHAFT IN AN L3/4 OLIF WITH PERC SCREWS FOR AN UNKNOWN SPINAL INDICATION. IT WAS REPORTED THAT WHILE MALLETING IN THE PIVOX IMPLANT, THE INSERTER SHAFT BROKE RIGHT AT THE THREADED JUNCTION. THERE WERE 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 17141343 ↗
• MalfunctionMay 18, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH L1-S1 OLIF. THER APY. PREOPERATIVE SYMPTOMS DIAGNOSIS WAS SCOLIOSIS. IT WAS REPORTED THAT THE DISTAL TIP OF THE INSERTER'S SHAFT BROKE OFF WHILE THE SURGEON WAS TRYING TO ADJUST THE POSITION OF THE CAGE AT L1/2. THE TIP WAS RECOVERED FROM THE PATIENT BODY BUT IT WAS DISCARDED BY HOSPITAL STAFF. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16950984 ↗
• MalfunctionApr 24, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING AN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT TRIED TO IMPLANT THE DEVICE THE TIP OF THE INSERTER BROKE OFF IN THE CAGE. THERE WERE NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE THREAD OF THE INSERTER WAS STUCK IN THE CAGE AND COULD THEREFORE NOT BE USED AGAIN. THE REPORTED PRODUCTS CAME IN CONTACT WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16794157 ↗
• MalfunctionApr 12, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING OLIF L2/3 L3/4 L4/5 FOR SHORT SEGMENT DEGENERATIIVE SCOLIOSIS. IT WAS REPORTED THAT BOTH INSERTERS WERE SHEARED OFF. NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16723088 ↗
• MalfunctionJan 9, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING OLIF L2-S1 FOR LUMBAR STENOSIS. IT WAS REPORTED THAT DURING NORMAL USAGE, THE SURGEON WAS IMPACTING THE INSERTER AND THE INSERTER TIP SHEARED OFF AT THE IMPLANT INTERFACE. THE IMPLANT WITH BROKEN TIP WAS EXTRACTED AND REPLACED WITH NEW IMPLANT. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16119624 ↗
• MalfunctionDec 21, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL(HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING DEVICES USED IN OBLIQUE LATERAL INTERBODY FUSION(OLIF). IT WAS REPORTED THAT THE THREADED TIP WAS BROKEN ON INSERTION AND THE PITUITARY WAS BROKEN. THE PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE WAS SEVERE FORAMINAL STENOSIS AND SCOLIOSIS. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. HENCE, NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE THREADED TIP OF THE PITUITARY BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16020841 ↗
• MalfunctionDec 13, 2022Break; Break

  ADDITIONAL INFORMATION RECEIVED THAT PRE-OP DIAGNOSIS FOR THE PATIENT WAS SPINAL STENOSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15968124 ↗
• MalfunctionOct 15, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR DEFORMITY CORRECTION. IT WAS REPORTED THAT, TWO (X2) OF THE INTERBODY INSERTER THREADED SHAFTS BROKE DURING PIVOX INTERBODY IMP LANTATION AT L3-4. THERE WERE NO BROKEN FRAGMENTS OF INSERTER LEFT INSIDE PATIENT BODY. THE PROCEDURE OR TECHNIQUE PERFORMED WAS OBLIQUE LUMBAR INTERBODY FUSION AND THE LEVELS IMPLANTED WERE L2-L5. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED. NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15612519 ↗
• MalfunctionOct 15, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR DEFORMITY CORRECTION. IT WAS REPORTED THAT, TWO (X2) OF THE INTERBODY INSERTER THREADED SHAFTS BROKE DURING PIVOX INTERBODY IMP LANTATION AT L3-4. THERE WERE NO BROKEN FRAGMENTS OF INSERTER LEFT INSIDE PATIENT BODY. THE PROCEDURE OR TECHNIQUE PERFORMED WAS OBLIQUE LUMBAR INTERBODY FUSION AND THE LEVELS IMPLANTED WERE L2-L5. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED. NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15612516 ↗
• MalfunctionSep 21, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A SPINAL PRODUCT THAT WAS USED IN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE INNER SHAFT OF THE PRODUCT WAS BROKEN. NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE WERE NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT AND NO REVISION SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15460809 ↗
• MalfunctionAug 24, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L3/4 OLIF. IT WAS REPORTED THAT UNDER IMPACTION OF THE PIVOX CAGE INTO THE L3/4 DISC SPACE, THE THREADED PART OF THE FIRST INSERTER SHEARED OFF. THE BROKEN PIECE REMAINED IN THE IMPLANT AND IT WAS EXTRACTED VIA A NEEDLE-HOLDER. A SMALLER CAGE WAS OPENED AND THEN USED THE SECOND THREADED INSERTER AND EXACTLY THE SAME THING OCCURRED AFTER A FEW BLOWS WITH THE MALLET. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15280739 ↗
• MalfunctionAug 17, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIA GNOSIS FOR DISC DEGENERATIVE DISEASE. PROCEDURE OR TECHNIQUE USED WAS OLIF. LEVELS IMPLANTED L2-5. IT WAS REPORTED THAT THE TIP OF BOTH THE INTERBODY INSERTER THREADED SHAFT BROKE DURING IMPLANTATION. THERE WAS NO FRAGMENT LEFT INSIDE THE PATIENT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15238351 ↗
• MalfunctionAug 11, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L3/4 OLIF. IT WAS REPORTED THAT UNDER IMPACTION OF THE PIVOX CAGE INTO THE L3/4 DISC SPACE, THE THREADED PART OF THE FIRST INSERTER SHEARED OFF. THE BROKEN PIECE REMAINED IN THE IMPLANT AND IT WAS EXTRACTED VIA A NEEDLE-HOLDER. A SMALLER CAGE WAS OPENED AND THEN USED THE SECOND THREADED INSERTER AND EXACTLY THE SAME THING OCCURRED AFTER A FEW BLOWS WITH THE MALLET. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15211402 ↗
• MalfunctionAug 10, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING LUMBAR INTERNAL FIXATION AND FUSION SURGERY DUE TO LUMBAR SPONDYLOLISTHESIS. IT WAS REPORTED THAT AFTER THE INNER CORE OF THE IMPLANTATION PRODUCT WAS BROKEN, ITS TIP REMAINED IN THE THE IMPLANTATION PRODUCT. IT WAS CONFIRMED THAT THE REPORTED SHAFT BROKE AND BROKEN TIP REMAINED IN IMPLANT. 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 15201015 ↗
• MalfunctionAug 2, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING OLIF PROCEDURE AT THE L4-5 DISC LEVEL DUE TO DEGENRATIVE DISC DISEASE. IT WAS REPORTED THAT THREADED INSERTER TIP BROKE WHILE INSERTING/ADJUSTING THE PIVOX CAGE. THERE WAS NO PATIENT SYMPTOM REPORTED. INSERTER CAME IN CONTACT WITH PATIENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15145194 ↗
• MalfunctionJun 24, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A THREADED INSERTER SHAFT USED FOR SPINAL SURGERY. PRE-OP DIAGNOSIS WAS DEGENERATIVE DISK DISEASE. PROCEDURE PERFORMED IN THE EVENT WAS L3-5 OLIF. IT WAS REPORTED THAT INTRA-OPERATIVELY, UPON INSERTION OF PIVOX SPACER THE DISTAL TIP OF THREADED INSERTER SHAFT BROKE. SURGEON USED AN IMPACTOR TO FINAL POSITION THE SPACER WITH NO DIFFICULTY. THE BROKEN PIECE OF THREADED INSERTER WAS LEFT IN PLACE, IT BROKE "FLUSH" WITH INSERTION THREADED PORTION OF THE PIVOX SPACER RENDERING IT IMPOSSIBLE TO REMOVE. SURGEON PLACED A SMALL 2-HOLE LATERAL PLATE OVER THE PIVOX SPACER AS IS HIS NORMAL SURGICAL TECHNIQUE. THIS WAS AT THE L3-4-DISC SPACE. THREADED INSERTER WAS IN CONTACT WITH THE IMPLANT, WHICH WAS IN CONTACT WITH PATIENT, BUT THREADED INSERTER WASN¿T EVER IN DIRECT CONTACT WITH PATIENT. THERE WAS A DELAY OF 5 MINUTES IN THE OVERALL PROCEDURE TIME. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14797596 ↗
• MalfunctionJun 20, 2022Break; Break

  THE INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT FOR SPINAL THERAPY. IT WAS REPORTED THAT DURING IMPACTING THE IMPLANT, THE INSERTER BROKE OFF WHERE IT ATTACHES TO THE CAGE. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14742388 ↗
• 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 14487129 ↗
• MalfunctionMay 18, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING OLIF THERAPY. IT WAS REPORTED THAT THE TIP OF THREADER BROKE DURING PLACEMENT OF IMPLANT. THERE WAS NO FRAGMENT LEFT IN THE PATIENT. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14433257 ↗
• MalfunctionMay 18, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING AN UNKNOWN SPINAL PROCEDURE IN A PATIENT DIAGNOSED WITH FORAMINAL STENOSIS. IT WAS REPORTED THAT THE THREADED TIP BROKE OFF WHILE INSERTING CAGE. PRODUCT CAME IN CONTACT AND WAS REMOVED FROM PATIENT, NO EXTRA WORK WAS NEEDED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14432881 ↗
• MalfunctionMay 7, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH OLIF THERAPY. IT WAS REPORTED THAT THE CORE OF THE HOLDER FRACTURED DURING THE DRIVE INTO THE FUSION CAGE, LEAVING ITS FRONT METAL PORTION IN THE PATIENT'S BODY, WHICH COULD NOT BE REMOVED. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. THERE ARE CURRENTLY NO OTHER SURGICAL PLANS AND THE PATIENT HAS NOT BEEN DISCHARGED FROM THE HOSPITAL. THE SIZE OF THE PRODUCT SELECTED BY THE OPERATOR WAS IN LINE WITH THE PATIENT'S VERTEBRAL BODY SIZE AND TREATMENT NEEDS. THE OPERATOR'S OPERATION IN THE PERCUSSION PROCESS CONFORMED TO THE GUIDANCE REQUIREMENTS IN OUR OPERATION MANUAL. AFTER THE PRODUCT BROKE IN THE PATIENT'S BODY, IT COULD NOT BE TAKEN OUT. SINCE THE FUSION CAGE WAS IMPLANTED IN PLACE, IF IT WAS TAKEN OUT HARD, IT WOULD CAUSE ADDITIONAL HARM TO THE PATIENT, SO IT COULD NOT BE REMEDIED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 14314448 ↗
• MalfunctionMay 5, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP OF THE REPORTED PRODUCTS. IT WAS REPORTED THAT, THREE PIVOX INNER SHAFTS BROKE DURING A THREE LEVEL OBLIQUE LATERAL INTERBODY FUSION (OLIF). THERE WERE NO FRAGMENTS OF BROKEN INSTRUMENTS REMAINS IN PATIENT BODY. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14285509 ↗
• MalfunctionMay 5, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP OF THE REPORTED PRODUCTS. IT WAS REPORTED THAT, THREE PIVOX INNER SHAFTS BROKE DURING A THREE LEVEL OBLIQUE LATERAL INTERBODY FUSION (OLIF). THERE WERE NO FRAGMENTS OF BROKEN INSTRUMENTS REMAINS IN PATIENT BODY. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14285446 ↗