MAYFIELD HEAD HOLDER ADAPTOR ROSA3-177DRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03760244031235), received between Jul 2, 2019 and Jul 2, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

7 other recalls cover devices cleared under the same FDA submission (K151359); 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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2019Break; Mechanical Jam; Break; Mechanical Jam

  PRIOR TO ANY INCISIONS, THE LOCAL FIELD SERVICE ENGINEER, WENT TO LOOSEN THE MAYFIELD HEAD HOLDER ADAPTOR IN ORDER TO PREPARE IT FOR FIXATION TO THE LEKSELL HEAD HOLDER. WHEN ATTEMPTING TO LOOSEN, THE GEAR PORTION OF THE HEAD HOLDER ADAPTOR WOULD NOT DISENGAGE. AFTER ATTEMPTING MANY TIMES, THE THREADED COMPONENT THAT HOLDS THE RATCHETING ARM IN PLACE ENDED UP SNAPPING INTO TWO PIECES. THIS DID NOT DELAY SURGERY. THERE WAS LESS THAN A 5 MINUTES DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 8753317 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K151359. One submission often covers many models, so check the product and lot details in each record.

• Z-1150-2020 · Jan 6, 2020 · Terminated
  ROSA Brain 3.0 Application-Brain
• Z-1151-2020 · Jan 6, 2020 · Terminated
  ROSA One 3.1 Brain Application
• Z-0172-2020 · Sep 10, 2019 · Terminated
  Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wooden case and protected with plastic bubble and plastic film. Seals are put on the crate. The product i
• Z-1754-2017 · Feb 27, 2017 · Terminated
  MEDTECH ROSA Brain 3.0 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosu
• Z-2868-2017 · Oct 11, 2016 · Terminated
  ROSA Brain, 3.0.0 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgica
• Z-0116-2018 · Jul 29, 2016 · Terminated
  ROSA BRAIN 3.0.0
• Z-0167-2018 · Jul 20, 2016 · Terminated
  ROSA Brain 3.0.0 Usage: The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neuro