Solera NAV2020KRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00643169545816), received between May 16, 2017 and Dec 5, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Break” (10 reports).

1 other recall cover devices cleared under the same FDA submission (K140454); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionApr 3, 2019Break; Break

  TYPE OF SURGICAL PROCEDURE: SPINAL FUSION IT WAS REPORTED THAT INTRA-OP, SCREWDRIVER WAS BROKEN DURING A SURGERY. NO PATIENT COMPLICATIONS WERE REPORTED DURING THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8477542 ↗
• InjuryOct 25, 2017Break; Break

  PRE-OP DIAGNOSIS: DIAGNOSTIC OSTOMYELITE L5 REVISION CASE LUMBOSACRAL. PROCEDURE: PEDICLE SCREW REVISION IN THE LUMBAR/ SACRAL REGION IT WAS REPORTED THAT DURING SURGERY, THE DISTAL TIP OF THE DRIVER BROKE AND WAS LEFT INSIDE THE TULIP OF THE SCREW IN S1. THE S1 RIGHT AND LEFT WAS PREPARED USING THE DRILL AND THE 8.5 MM TAP. THEN THE SCREW WAS IMPLANTED USING THE 2 DIFFERENT SCREWDRIVERS IN FAULT. BOTH THE DRIVES CONTACTED THE PATIENT AND BROKE. FRAGMENTS REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6975562 ↗
• MalfunctionMay 16, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR LUMBAR FUSION AT L3-PELVIS. INTRA-OPERATIVELY, DURING THE PLACEMENT OF SCREW , THE TIP OF THE DRIVE BROKE-OFF INSIDE SCREW. THE BROKEN PIECE WAS REMOVED AND THROWN OUT. NO FRAGMENTS OF THE PRODUCT REMAINED INSIDE PATIENT. THE PRODUCT CAME IN CONTACT WITH PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6568405 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140454. One submission often covers many models, so check the product and lot details in each record.

• Z-2363-2023 · Jul 12, 2023 · Open, Classified
  CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K