Solera NAV2006KRecalls & reported problems
Medtronic Sofamor Danek, Inc. · TAP NAV2006K SOLERA AWLTIPTAP 6.5MM · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169540958), received between Jul 9, 2025 and Jul 11, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Inaccurate Information” (5 reports).
1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Jul 12, 2023Open, Classified
Incorrect Laser Marking - Solera Awl Tip Tap
Z-2363-2023 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Inaccurate Information5
- Manufacturing, Packaging or Shipping Problem5
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
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 ↗
Other Orthopedic stereotaxic instrument devices
- REAL INTELLIGENCE ROB10024Smith & Nephew, Inc. · Orthopedic stereotaxic instrument1 recall924 reports
- NA 209063Mako Surgical Corp. · Orthopedic stereotaxic instrument2 recalls602 reports
- RESTORIS, RIO 212760Mako Surgical Corp. · Orthopedic stereotaxic instrument605 reports
- REAL INTELLIGENCE ROB10013Smith & Nephew, Inc. · Orthopedic stereotaxic instrument1 recall528 reports
- VELYS 4515-70-105Depuy (Ireland) · Orthopedic stereotaxic instrument578 reports
- VELYS 4515-70-106Depuy (Ireland) · Orthopedic stereotaxic instrument564 reports
- NA 209999Mako Surgical Corp. · Orthopedic stereotaxic instrument522 reports
- Mazor X System TPL0059-06Mazor Robotics Ltd · Orthopedic Stereotaxic Instrument2 recalls2 deaths392 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.