NA 111655Recalls & reported problems
Mako Surgical Corp. · VARIABLE ANGLE FIXATION SCREW · Class 2 · Implant
- 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 00848486017323), received between Mar 16, 2020 and Dec 3, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
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
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
- Material Fragmentation1
Patient problems
- Bone Fracture(s)1
- Foreign Body In Patient1
- Hip Fracture1
- 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.
MalfunctionDec 3, 2025Material Fragmentation; Material Fragmentation
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23705235 ↗InjuryNov 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE LAYER WAS REMOVED AND CLOSED USING THE MAKO OPERATION, AND A POSTOPERATIVE X-RAY REVEALED THAT ONLY THE WASHER PORTION REMAINED IN THE LAYER. THE WOUND WAS REOPENED BEFORE PATIENT AWAKENING AND THE WASHER WAS REMOVED.
Patient problems: Foreign Body In Patient
MAUDE report 15787770 ↗InjuryMar 16, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
THA WITH MAKO (DIRECT ANTERIOR APPROACH). USED ENHANCED WORKFLOW, SO USED VARIABLE CORTICAL SCREW AROUND PROXIMAL FEMUR. PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEM. GREATER TROCHANTER FRACTURE WAS HAPPENED PROBABLY DURING REHABILITATION. SALES REP WAS INFORMED THAT 3 SIMILAR CASES HAPPENED. IN SURGEON'S OPINION, THIS EVENT HAPPENED DUE TO USE OF VARIABLE CORTICAL SCREW, BUT DIRECT CAUSE WAS UNKNOWN. ANOTHER POSSIBILITY IS THAT BONE IS THIN AROUND GREATER TROCHANTER BECAUSE THEY USED ANTERIOR APPROACH. IN ADDITION, THERE IS A POSSIBILITY THAT THE SCREW MAY INTERFERE MANY TIMES DURING RETRACTION OF THE FEMUR OR TRIAL. WHETHER TO PERFORM REVISION SURGERY IS UNDECIDED.
Patient problems: Bone Fracture(s); Hip Fracture
MAUDE report 9837995 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.