DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemRecalls & reported problems across all models
Medtronic Sofamor Danek, Inc. · 14 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 32
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls
- 0
We found 14 models of DIVERGENCE-L Anterior/Oblique Lumbar Fusion System by Medtronic Sofamor Danek, Inc. in the FDA's device registry (GUDID). Together they are named in 32 adverse event reports in the FDA's MAUDE database, received between May 9, 2017 and Nov 19, 2025 — classified as 12 injuries, 20 malfunctions.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (27 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 DIVERGENCE-L Anterior/Oblique Lumbar Fusion System problems
Device problems
- Migration or Expulsion of Device27
- Break2
- Device Dislodged or Dislocated1
- Material Twisted/Bent1
- Product Quality Problem1
Patient problems
- No Known Impact Or Consequence To Patient16
- Pain11
- No Clinical Signs, Symptoms or Conditions5
DIVERGENCE-L Anterior/Oblique Lumbar Fusion System models
14 models, most reported first. Each model has its own page with its reports, recalls and device details.
- DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System 2150125APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY9 reports
- DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System 2150130Intervertebral fusion device with integrated fixation, lumbar7 reports
- DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System 2150135Intervertebral fusion device with integrated fixation, lumbar3 reports
- DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System 2152110Intervertebral fusion device with integrated fixation, lumbar2 reports
- DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System 2160010Intervertebral fusion device with integrated fixation, lumbar2 reports
- DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System 2151116APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System 2152112APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System 2160016Intervertebral fusion device with bone graft, lumbar1 report
- DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System 2160014Intervertebral fusion device with integrated fixation, lumbar1 report
- DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System 2160012APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System 2150018Intervertebral fusion device with bone graft, lumbar1 report
- DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System 2151100Intervertebral fusion device with integrated fixation, lumbar1 report
- DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System 2160212APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System 2160214APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
Recent DIVERGENCE-L Anterior/Oblique Lumbar Fusion System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionNov 19, 2025Product Quality Problem; Product Quality Problem
INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT. IT WAS REPORTED THAT THE SCREW IS MANUFACTURED POORLY. THE SCREW HAS SHARDS OF METAL STICKING OUT OF THE SCREW SHAFT. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23590806 ↗MalfunctionJun 10, 2025Material Twisted/Bent; Material Twisted/Bent
INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT AFTER SURGERY, THE THREADS BROKE OFF THE RASP WHEN ATTEMPTING TO REMOVE IT AND THE INNER TUBE OF THE ALIF SCREW GUIDE APPEARED TO BE BENT INSIDE THE INSTRUMENT. THE HANDLE WAS BROKEN. THERE WAS NO PATIENT INVOLVED AND NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22173748 ↗MalfunctionJun 10, 2025Break; Break
INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT AFTER SURGERY, THE THREADS BROKE OFF THE RASP WHEN ATTEMPTING TO REMOVE IT AND THE INNER TUBE OF THE ALIF SCREW GUIDE APPEARED TO BE BENT INSIDE THE INSTRUMENT. THE HANDLE WAS BROKEN. THERE WAS NO PATIENT INVOLVED AND NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22173744 ↗InjuryJan 6, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT WITH PROCEDURE OLIF L5-S1 WITH SCREW FIXATION L4-5-S1. IT WAS REPORTED THAT THE SCREW WAS REPOSITIONED S1, RT. PATIENT WAS HOSPITALIZED OR A PROLONGATION OF AN EXISTING HOSPITALIZATION FROM (B)(6) 2023 TILL (B)(6) 2023. OUTCOME OF THIS AE: RECOVERED/RESOLVED AE END: (B)(6) 2023 RIGHT S1 SCREW REMOVE AND S1 SCREW REPOSITION. PATIENT HAD NO COMPLICATIONS. LT L5 ROOT DECOMPRESSION. THE SEVERITY OF ADVERSE EVENT WAS MINOR. AFTER SURGERY, THE SCREW WAS DISLODGEMENT AND REPOSITIONING WAS PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18461080 ↗MalfunctionOct 19, 2021Break; Break
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH SPINAL THERAPY. IT WAS REPORTED THAT THE INSERTER HANDLE INSTRUMENT BROKE AND THE MAIN SCREW FOR THE PITUITARY RONGEUR INSTRUMENT FELL OUT DURING USE. 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 12653043 ↗MalfunctionNov 16, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT POST-OP, SCREWS MIGRATED ANTERIORLY. NO FUTURE SURGERY WAS PLANNED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7037760 ↗MalfunctionNov 16, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT POST-OP, PLATE MIGRATED ANTERIORLY. NO FUTURE SURGERY WAS PLANNED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7037754 ↗MalfunctionNov 16, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT POST-OP, THE INTERBODY MIGRATED ANTERIORLY. NO FUTURE SURGERY WAS PLANNED. PATIENT WILL BE KEPT UNDER OBSERVATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7037708 ↗InjuryNov 10, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT, POST-OP, ENTIRE CONSTRUCT MIGRATED FORWARD AND SCREWS PULLED OUT. ONGOING LEG PAIN AND BACK PAIN WAS REPORTED. NO SURGERY IS CURRENTLY SCHEDULED.
Patient problems: Pain
MAUDE report 7019725 ↗InjuryNov 10, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT, POST-OP, ENTIRE CONSTRUCT MIGRATED FORWARD AND SCREWS PULLED OUT. ONGOING LEG PAIN AND BACK PAIN WAS REPORTED. NO SURGERY IS CURRENTLY SCHEDULED.
Patient problems: Pain
MAUDE report 7019712 ↗InjuryNov 10, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT, POST-OP, ENTIRE CONSTRUCT MIGRATED FORWARD AND SCREWS PULLED OUT. ONGOING LEG PAIN AND BACK PAIN WAS REPORTED. NO SURGERY IS CURRENTLY SCHEDULED.
Patient problems: Pain
MAUDE report 7019691 ↗InjuryNov 10, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT, POST-OP, ENTIRE CONSTRUCT MIGRATED FORWARD AND SCREWS PULLED OUT. ONGOING LEG PAIN AND BACK PAIN WAS REPORTED. NO SURGERY IS CURRENTLY SCHEDULED.
Patient problems: Pain
MAUDE report 7019522 ↗InjuryNov 10, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT, POST-OP, ENTIRE CONSTRUCT MIGRATED FORWARD ONGOING LEG PAIN AND BACK PAIN WAS REPORTED. NO SURGERY IS CURRENTLY SCHEDULED.
Patient problems: Pain
MAUDE report 7019518 ↗InjuryNov 10, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT, POST-OP, ENTIRE CONSTRUCT MIGRATED FORWARD. ONGOING LEG PAIN AND BACK PAIN WAS REPORTED. NO SURGERY IS CURRENTLY SCHEDULED.
Patient problems: Pain
MAUDE report 7019406 ↗MalfunctionNov 10, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT POST-OP, THE INTERBODY DEVICE MIGRATED FORWARD. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. NO OTHER INFO IS AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7018708 ↗
Other Medtronic Sofamor Danek, Inc. products
- CD HORIZON Spinal System342 models · 2,323 reports
- GRAFTONand GRAFTON PLUSDemineralized Bone Matrix (DBM)25 models · 12 reports · 16 recalls
- 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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