SoleraRecalls & reported problems across all models
Medtronic Sofamor Danek, Inc. · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Solera model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 1
We found 6 models of Solera by Medtronic Sofamor Danek, Inc. in the FDA's device registry (GUDID). Together they are named in 19 adverse event reports in the FDA's MAUDE database, received between May 16, 2017 and Dec 5, 2025 — classified as 2 injuries, 17 malfunctions.
The most frequently reported specific device problem is “Break” (12 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
Solera recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jul 12, 2023Open, Classified
Incorrect Laser Marking - Solera Awl Tip Tap
Z-2363-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported Solera problems
Device problems
- Break12
- Inaccurate Information5
- Manufacturing, Packaging or Shipping Problem5
- Detachment of Device or Device Component1
- Material Deformation1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- No Known Impact Or Consequence To Patient3
- Device Embedded In Tissue or Plaque2
- Spinal Cord Injury1
Solera models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Solera NAV2006KOrthopedic stereotaxic instrument1 recall5 reports
- Solera NAV2020KOrthopedic stereotaxic instrument10 reports
- Solera NAV2002KOrthopedic stereotaxic instrument1 report
- Solera NAV2016KOrthopedic stereotaxic instrument1 report
- Solera NAV2019KOrthopedic stereotaxic instrument1 report
- Solera NAV2025KOrthopedic stereotaxic instrument1 report
Recent Solera adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionDec 5, 2025Break; Break
INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT, THE INSTRUMENT WAS DEFECTIVE. THE TIP OF THE SCREWDRIVER BROKEN OFF. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23727870 ↗MalfunctionAug 6, 2025Mechanical Problem; Mechanical Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE INSTRUMENT HEAD WAS STRIPPED, THEREFORE THE SCREW WAS UNABLE TO BE PLACED WITH NAVIGATION. THE HEALTH CARE PROFESSIONAL REVERTED TO USING A NON-NAVIGATED DRIVER INSTRUMENT INSTEAD. THERE WAS A DELAY OF 5 -10 MINUTES. NO REPORTED IMPACT ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22729288 ↗MalfunctionJul 11, 2025Manufacturing, Packaging or Shipping Problem; Inaccurate Information; Manufacturing, Packaging or Shipping Problem; Inaccurate Information
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A DEVICE USED FOR SPINAL THERA PY. IT WAS REPORTED THAT THE INSTRUMENT WAS LABELED "4.5" INSTEAD OF BEING LABELED "6.5". 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 22477665 ↗MalfunctionJul 10, 2025Manufacturing, Packaging or Shipping Problem; Inaccurate Information; Manufacturing, Packaging or Shipping Problem; Inaccurate Information
INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A PRODUCT. IT WAS REPORTED THAT THE TAPS WERE LABELED AS "4.5" INSTEAD OF BEING LABELED "6.5". THERE WAS NO PATIENT INVOLVED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22466471 ↗MalfunctionJul 10, 2025Manufacturing, Packaging or Shipping Problem; Inaccurate Information; Manufacturing, Packaging or Shipping Problem; Inaccurate Information
INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A PRODUCT. IT WAS REPORTED THAT THE TAPS WERE LABELED AS "4.5" INSTEAD OF BEING LABELED "6.5". THERE WAS NO PATIENT INVOLVED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22466460 ↗MalfunctionJul 10, 2025Manufacturing, Packaging or Shipping Problem; Inaccurate Information; Manufacturing, Packaging or Shipping Problem; Inaccurate Information
INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A PRODUCT. IT WAS REPORTED THAT THE TAPS WERE LABELED AS "4.5" INSTEAD OF BEING LABELED "6.5". THERE WAS NO PATIENT INVOLVED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22466444 ↗MalfunctionJul 9, 2025Manufacturing, Packaging or Shipping Problem; Inaccurate Information; Manufacturing, Packaging or Shipping Problem; Inaccurate Information
INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY VIA MANUFACTURER REPRESENTATIVE REGARDING A TAP USED IN SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE WAS LABELED AS 4.5 INSTEAD OF BEING LABELED 6.5. NO PATIENT WAS INVOLVED IN THE EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22456187 ↗MalfunctionApr 18, 2025Break; Break
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A SCREWDRIVER USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE SCREWDRIVER WAS DEFECTIVE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE ACTUAL ALLEGATION ASSOCIATED WITH THE REPORTED PRODUCT IN THE EVENT WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21867163 ↗MalfunctionApr 8, 2025Break; Material Deformation; Break; Material Deformation
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING T10-L3 INSTRUMENTED FUSION WITH PELVIC FIXATION, AND REVISION OF HARDWARE FROM L3-S1. IT WAS REPORTED THAT MULTIPLE DRIVERS BROKE/STRIPPED WHILE MD ATTEMPTED TO REMOVE OLD HARDWARE. ALL OLD HARDWARE WAS EVENTUALLY EXPLANTED, AND THE LEVELS REINSTRUMENTED WITH FRESH SCREWS/RODS. 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 21794861 ↗MalfunctionMar 28, 2025Break; Break
INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED PRIOR TO USE. IT WAS REPORTED THAT TIP OF THE DRIVER BROKE OFF. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21718042 ↗MalfunctionMar 17, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR FIXAT ION FOR AN INDICATION OF TRAUMA LISTHÉSIS. IT WAS REPORTED THAT THE TIP OF SCREWDRIVER WAS BROKEN DURING FINAL ILIAC SCREW INSERTION AND THE BROKEN TORX TIPS OF RELATED SCREWDRIVERS REMAIN IN THE IMPLANTED SCREWS. THERE IS NO PLAN OF REVISION SURGERY FOR REMOVAL OF DEVICE FRAGMENTS. 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 21615966 ↗MalfunctionOct 4, 2024Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DRIVER. IT WAS REPORTED THAT D RIVER WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20367998 ↗MalfunctionOct 3, 2024Break; Break
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE TIP OF THE DEVICE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20356853 ↗InjuryJun 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT, WHILE USING THE NAVIGATED TAP, INSTRUMENT DISENGAGED FROM HANDLE AND FALLEN INTO SURGICAL WOUND CAUSING DURAL TEAR. THE DURA WAS TORN AT THE LEVELS T11-T12 AND WAS CLOSED. PROCEDURE OR TECHNIQUE PERFORMED WAS POSTERIOR ARTHRODESIS T11 TO T12, POSTERIOR ARTHRODESIS OF T9-T10 AND T10-T11, POSTERIOR INSTRUMENTATION T9-T12. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: Spinal Cord Injury
MAUDE report 19445737 ↗MalfunctionNov 17, 2021Break; Break
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING PATIENT WAS IMPLANTED WITH A SCREW USING A DRIVER IN AN UNKNOWN SPINAL THERAPY FOR AN L3-S1 REVISION CASE. IT WAS REPORTED THAT THE SCREWDRIVER TIP BROKE WHEN THE SCREW WAS PUT HALFWAY-IN. THE TIP IS STILL STUCK INSIDE THE SCREW HEAD UNDER THE SADDLE OF THE TULIP. THE SCREW WAS REMOVED AND CHANGED TO A NEW ONE, ALONG WITH CHANGE OF NAVIGATED SCREWDRIVER. THERE WAS NO ALLEGATIONS AIMED TOWARDS THE SCREW. THE BONE WAS VERY HARD ACCORDING TO THE SURGEON. THE DATE OF IMPLANT AND EXPLANT FOR SCREW WAS (B)(6) 2021. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THE EVENT. THERE WAS NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12825297 ↗
Other Medtronic Sofamor Danek, Inc. products
- CD HORIZON Spinal System342 models · 2,323 reports
- GRAFTONand GRAFTON PLUSDemineralized Bone Matrix (DBM)25 models · 12 reports · 14 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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