NA 144170Recalls & reported problems
Mako Surgical Corp. · BONE PINS (4MM X 170MM) · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00848486018184), received between Jun 11, 2018 and May 15, 2024 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Non Reproducible Results” (2 reports).
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
Most reported problems
Device problems
- Non Reproducible Results2
- Break1
- Fracture1
- Insufficient Device Problem Information1
Patient problems
- No Known Impact Or Consequence To Patient2
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 15, 2024Fracture; Fracture
THE FOLLOWING WAS REPORTED: "SURGEON WAS USING A POWER TOOL TO REMOVE THE BONE PINS FROM THE PATIENT AT THE END OF THE CASE. AS HE WAS TAKING OUT ONE OF THE PINS, ONLY HALF CAME OUT. WITH FURTHER INSPECTION HE REALISED THAT THE OTHER HALF WAS STILL IN THE PATIENT, IN THE BONE. SURGEON OPENED UP THE SMALLER INCISION AND MANAGED TO PULL OUT THE BROKEN PIECE USING FORCEPS. THE STRYKER MAKO REP THAT WAS PRESENT SAID HE WAS GOING TO REPORT IT TO STRYKER AND ASK IF IT HAD HAPPENED WITH THAT PRODUCT BEFORE.".
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19320348 ↗MalfunctionJul 1, 2019Break; Non Reproducible Results; Break; Non Reproducible Results
POST OP WHEN DR. (B)(4) WAS TRYING TO REMOVE THE LAST 4 X 170 BONE PIN FROM THE FEMUR THE BONE PIN BROKE OFF IN THE PATIENT. WE HAVE NOT SEEN THIS BEFORE AND WANTED TO BRING AWARENESS TO THE ISSUE FROM TODAY. CASE TYPE: TKA.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8748206 ↗InjuryJun 11, 2018Insufficient Device Problem Information; Non Reproducible Results; Insufficient Device Problem Information; Non Reproducible Results
AS REPORTED: CONVERSATION WITH DR. (B)(6) ABOUT HAVING ISSUES WITH THE 4X140 AND 4X170 PINS CRACKING THE FEMORAL CORTEX WHEN BEING DRILLED IN FOR ARRAY PLACEMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7586299 ↗
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- 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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