Solera NAV2002KRecalls & reported problems
Medtronic Sofamor Danek, Inc. · TAP NAV2002K SOLERA AWLTIPTAP 4.5MM · Class 2
All models of Solera (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169540910), received between Jun 3, 2024 and Jun 3, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- Spinal Cord Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 ↗
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, ClassifiedCD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K
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- 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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