TPLAN® Planning Station 109000Recalls & reported problems
Think Surgical, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M9461090000), received between Sep 12, 2024 and Jan 16, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
1 other recall cover devices cleared under the same FDA submission (K230202, K232802, K241031); 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Insufficient Device Problem Information1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 16, 2026Insufficient Device Problem Information
THE SURGEON REQUESTED A POSTERIOR REFERENCING PLAN; HOWEVER, THE PLAN UPLOADED FOR THE PROCEDURE WAS ANTERIOR REFERENCING. THIS DISCREPANCY WAS NOT IDENTIFIED PRIOR TO THE PROCEDURE AND WAS DISCOVERED INTRAOPERATIVELY WHEN THE PINS WERE BEING PLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24096856 ↗MalfunctionSep 12, 2024No Apparent Adverse Event; Appropriate Device Problem Term/Code Not Available; No Apparent Adverse Event; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE SURGICAL PLAN WAS MADE USING THE BKS TRIMAX IMPLANTS RATHER THAN THE BKS CR IMPLANTS REQUESTED BY THE SURGEON. THE OR USER NOTICED THE DIFFERENCE IN THE IMPLANT MODEL AND NOTIFIED THE SURGEON. THE SURGEON MADE THE APPROPRIATE CHANGES TO REFLECT THE CORRECT IMPLANT AND APPROVED THE PLAN. CHANGES WERE MADE BEFORE THE CASE STARTED. NO DELAY AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20205948 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K230202, K232802, K241031. One submission often covers many models, so check the product and lot details in each record.
- Z-1318-2024 · Feb 12, 2024 · Open, ClassifiedAssembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic System
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 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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