PIVOX Oblique Lateral Spinal SystemRecalls & reported problems across all models
Medtronic Sofamor Danek, Inc. · 17 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 246
- Deaths reported
- 0
- Injuries reported
- 45
- Recalls
- 0
We found 17 models of PIVOX Oblique Lateral Spinal System by Medtronic Sofamor Danek, Inc. in the FDA's device registry (GUDID). Together they are named in 246 adverse event reports in the FDA's MAUDE database, received between Nov 18, 2016 and Mar 11, 2026 — classified as 45 injuries, 201 malfunctions.
The most frequently reported specific device problem is “Break” (205 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported PIVOX Oblique Lateral Spinal System problems
Device problems
- Break205
- Migration or Expulsion of Device14
- Migration8
- Device Dislodged or Dislocated4
- Mechanical Problem4
- Material Deformation3
- Mechanics Altered3
- Detachment of Device or Device Component2
Patient problems
- No Known Impact Or Consequence To Patient106
- No Clinical Signs, Symptoms or Conditions103
- Device Embedded In Tissue or Plaque28
- Pain20
- Failure of Implant4
- No Consequences Or Impact To Patient2
- Ambulation or Postural Difficulties1
- Bone Fracture(s)1
PIVOX Oblique Lateral Spinal System models
17 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PIVOX™ Oblique Lateral Spinal System 2161001Intervertebral fusion device with integrated fixation, lumbar182 reports
- PIVOX™ Oblique Lateral Spinal System 2140010Intervertebral fusion device with integrated fixation, lumbar13 reports
- PIVOX™ Oblique Lateral Spinal System 2161000Intervertebral fusion device with bone graft, lumbar9 reports
- PIVOX™ Oblique Lateral Spinal System 2140130APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY8 reports
- PIVOX™ Oblique Lateral Spinal System 2140001Intervertebral fusion device with integrated fixation, lumbar6 reports
- PIVOX™ Oblique Lateral Spinal System 2140135APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY5 reports
- PIVOX™ Oblique Lateral Spinal System 2141000Intervertebral fusion device with bone graft, lumbar5 reports
- PIVOX™ Oblique Lateral Spinal System 2140002Intervertebral fusion device with integrated fixation, lumbar4 reports
- PIVOX™ Oblique Lateral Spinal System 2140140APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY4 reports
- PIVOX™ Oblique Lateral Spinal System 2111255Intervertebral fusion device with integrated fixation, lumbar2 reports
- PIVOX™ Oblique Lateral Spinal System 2140020APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- PIVOX™ Oblique Lateral Spinal System 2111250Intervertebral fusion device with integrated fixation, lumbar1 report
- PIVOX™ Oblique Lateral Spinal System 2111355Intervertebral fusion device with bone graft, lumbar1 report
- PIVOX™ Oblique Lateral Spinal System 2131250Intervertebral fusion device with integrated fixation, lumbar1 report
- PIVOX™ Oblique Lateral Spinal System 2112355Intervertebral fusion device with bone graft, lumbar1 report
- PIVOX™ Oblique Lateral Spinal System 2140011APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- PIVOX™ Oblique Lateral Spinal System 2140012Intervertebral fusion device with bone graft, lumbar1 report
Recent PIVOX Oblique Lateral Spinal System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 11, 2026Break
INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT. IT WAS REPORTED THAT AFTER PIVOX PLATE WAS IMPLANTED THE INSERTER WAS DAMAGED WHILE REMOVING. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24567612 ↗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 ↗MalfunctionOct 16, 2025Break; Break
INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE INSERTER WAS BROKEN DURING WASH. 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 23308160 ↗MalfunctionAug 7, 2025Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A PATIENT HAVING OBLIQUE LATER AL INTERBODY FUSION. IT WAS REPORTED THAT THE BULLET DRIVER IS DAMAGED ON THE END THAT GETS MALLETED. ALSO, THE INSERTER AND THE GUIDE ARE NOT HOLDING ONTO PIVOX PLATE PROPERLY. 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 22735260 ↗MalfunctionMar 20, 2025Mechanical Problem; Mechanical Problem
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING OLIF (OBLIQUE LATERAL APPROACH FOR LUMBAR SPINE FUSION SURGERY). IT WAS REPORTED THAT THE IMPLANTATION PORT OF PRODUCT HAD A SLIPPERY PHENOMENON, WHICH MADE THE IMPLANTER UNABLE TO COOPERATE WITH THE PROSTHESIS. THERE WAS 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 21650060 ↗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 ↗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 ↗MalfunctionNov 15, 2023Break; Mechanics Altered; Break; Mechanics Altered
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT IS USED IN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE WASHER IN THE FLEX ARM IS BROKEN AND PIVOX PLATE INSERTER WILL NO LONGER HOLD PLATES. THERE IS NO PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18138455 ↗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 ↗InjuryAug 4, 2023Migration; Migration
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT USED IN OBLIQUE LATERAL 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 17457610 ↗InjuryAug 4, 2023Migration; Migration
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT USED IN OBLIQUE LATERAL INTERBODY FUSION (OLIF) THERAPY FOR DEGENERATIVE DISC DISEASE L2/3 AND L3/4. LEVELS IMPLANTED WAS L2/3 AND 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 17457572 ↗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 ↗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 17457540 ↗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 17457520 ↗InjuryJul 28, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
A POSTERIOR FIXATION AND DECOMPRESSION OF L2-L4 WAS PERFORMED ON (B)(6) 2023.
Patient problems: Pain
MAUDE report 17411933 ↗
Other Medtronic Sofamor Danek, Inc. products
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- METRx System5 models · 672 reports
- INFUSE Bone Graft6 models · 576 reports · 1 recall
- CD HORIZON SOLERA VOYAGER Spinal System60 models · 411 reports
- POWEREASE Instruments8 models · 331 reports · 1 recall
- Catalyft PL Expandable Interbody System16 models · 279 reports · 1 recall
- INFINITY Occipitocervical Upper Thoracic System35 models · 63 reports · 5 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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