EasyDrill Cranial Perforator Ø14 x Ø11 x 3mmRecalls & reported problems across all models
Micromar Indústria e Comércio Ltda · 6 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 207
- Deaths reported
- 0
- Injuries reported
- 134
- Recalls
- 0
We found 6 models of EasyDrill Cranial Perforator Ø14 x Ø11 x 3mm by Micromar Indústria e Comércio Ltda in the FDA's device registry (GUDID). Together they are named in 207 adverse event reports in the FDA's MAUDE database, received between Mar 16, 2017 and Feb 23, 2026 — classified as 134 injuries, 73 malfunctions.
The most frequently reported specific device problem is “Device Remains Activated” (189 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported EasyDrill Cranial Perforator Ø14 x Ø11 x 3mm problems
Device problems
- Device Remains Activated189
- Detachment of Device or Device Component9
- Fracture6
- No Apparent Adverse Event3
- Adverse Event Without Identified Device or Use Problem2
- Dull, Blunt2
- Failure to Auto Stop2
- Insufficient Device Problem Information2
Patient problems
- Perforation121
- No Clinical Signs, Symptoms or Conditions62
- Hemorrhage/Blood Loss/Bleeding24
- No Consequences Or Impact To Patient8
- Spinal Cord Injury8
- Insufficient Information6
- No Known Impact Or Consequence To Patient5
- Contusion4
EasyDrill Cranial Perforator Ø14 x Ø11 x 3mm models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EasyDrill Cranial Perforator Ø14 x Ø11 x 3mm DM0010FAADrills, Burrs, Trephines & Accessories (Compound, Powered)67 reports
- EasyDrill Cranial Perforator Ø14 x Ø11 x 3mm DM0010FAADrills, Burrs, Trephines & Accessories (Compound, Powered)54 reports
- EasyDrill Cranial Perforator Ø14 x Ø11 x 3mm DM0010FAADrills, Burrs, Trephines & Accessories (Compound, Powered)37 reports
- EasyDrill Cranial Perforator Ø14 x Ø11 x 3mm DM0010FAADrills, Burrs, Trephines & Accessories (Compound, Powered)31 reports
- EasyDrill Cranial Perforator Ø14 x Ø11 x 3mm DM0010FAADrills, Burrs, Trephines & Accessories (Compound, Powered)9 reports
- EasyDrill Cranial Perforator Ø14 x Ø11 x 3mm DM0010FAADrills, Burrs, Trephines & Accessories (Compound, Powered)9 reports
Recent EasyDrill Cranial Perforator Ø14 x Ø11 x 3mm adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionFeb 23, 2026Fracture; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE DRILLING PROCESS, THE DRILL BROKE, AND THE WHITE PLASTIC PART BECAME DETACHED FROM THE METAL PART. NO PATIENT IMPACT REPORTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24424736 ↗MalfunctionFeb 2, 2026Device Remains Activated; Failure to Auto Stop; No Apparent Adverse Event
IT WAS REPORTED THAT MALFUNCTION WITH A PERFORATOR ATTACHMENT, WHILE DOING LEFT SIDED BURR HOLES FOR THE EVACUATION OF A HEMATOMA. THE PERFORATOR WAS WORKING CORRECTLY FOR THE FIRST BURR HOLE BUT PLUNGED THROUGH THE SKULL ON THE SECOND BURR HOLE, THIS IS SUPPOSED TO HAVE A HARD STOP. EVERYTHING WAS CONNECTED CORRECTLY AND THE SETTINGS WERE NOT INCREASED ON THE ELECTRIC MIDAS. IT WAS REPORTED THAT THE PATIENT DID NOT SEEM TO BE INJURED BY THE PERFORATOR PLUNGING THROUGH THE SKULL. IT WAS REPORTED THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24231316 ↗MalfunctionDec 20, 2025Device Remains Activated; Device Remains Activated
IT WAS REPORTED THAT DURING THE CRANIOTOMY PROCEDURE, THERE WAS NO DISENGAGEMENT OF THE PERFORATOR WHEN MAKING A DRILL HOLE WHICH RESULTED IN AN INJURY AND IATROGENIC DURAL OPENING WITH ENDANGERMENT OF THE INTEGRITY OF THE CORTICAL SURFACE (SURFACE OF THE BRAIN).ON ADDITIONAL FOLLOW UP THERE WAS NO PATIENT IMPACT REPORTED.
Patient problems: Dural Tear; No Clinical Signs, Symptoms or Conditions; Perforation
MAUDE report 23858764 ↗MalfunctionDec 19, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A BURR HOLE PROCEDURE, THREE PERFORATORS BROKE WHILE DRILLING. IT WAS REPORTED THAT PROCEDURE WAS DELAYED BY 20 MINUTES AND PROCEDURE WAS COMPLETED USING A MANUAL DRILL INSTEAD OF THE INTENDED POWERED DEVICE. AT THE TIME OF REPORT, THERE WAS NO KNOWN IMPACT TO A PATIENT. ADDITIONAL DETAILS REGARDING PATIENT IMPACT IS BEING FOLLOWED FROM THE FACILITY. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO PATIENT OR STAFF IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23847012 ↗MalfunctionDec 9, 2025Device Remains Activated; Device Remains Activated
IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE PERFORATOR , THE PERFORATOR TOOL WAS VERY SLOW AND DID NOT CUT THE BONE EFFECTIVELY. A SECOND PERFORATOR BIT FROM THE SAME LOT NUMBER WAS USED, WHICH WENT THROUGH THE BONE AND DID NOT STOP AS INTENDED. THE PRODUCT HAD CONTACT WITH THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCTS. NO INTERVENTIONS WERE PERFORMED OR PLANNED. THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions; Perforation
MAUDE report 23756085 ↗MalfunctionDec 4, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING USE, THE PERFORATOR BROKE WHILE IN CONTACT WITH THE PATIENT. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCTS, AND NO INTERVENTION WAS PERFORMED OR PLANNED.
Patient problems: No Clinical Signs, Symptoms or Conditions; Perforation
MAUDE report 23713617 ↗MalfunctionNov 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PROCEDURE, THE SURGICAL TEAM USED A NEW PERFORATOR CUTTER, WHICH BECAME DAMAGED DURING USE. IT WAS REPORTED THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23666007 ↗MalfunctionNov 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PROCEDURE, THE SURGICAL TEAM USED A NEW PERFORATOR CUTTER WHICH BECAME DAMAGED DURING USE. IT WAS REPORTED THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23665357 ↗MalfunctionNov 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PROCEDURE, THE SURGICAL TEAM USED A NEW PERFORATOR CUTTER WHICH BECAME DAMAGED DURING USE. IT WAS REPORTED THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23654107 ↗MalfunctionNov 10, 2025Device Remains Activated; Device Remains Activated
IT WAS REPORTED THAT DURING A CRANIOTOMY, THE BLADE'S STOP MECHANISM OF THE PERFORATOR FAILED IN THE PRESENCE OF DURA MATER. WE ARE UNSURE WHETHER THE REPORTED PRODUCT WAS USED NEW OR REUSED, AS THE INSTITUTION REUSES MIDAS REX MEDICAL DEVICES FOR COST REASONS. IT WAS ALSO REPORTED THAT THERE WAS NO INTERVENTION WAS PERFORMED AND NO DELAY IN PROCEDURE. THE PRODUCT HAD CONTACT WITH THE PATIENT, AND THE PROCEDURE WAS COMPLETED USING THE REPORTED PRODUCT. AT THE TIME OF THE REPORT, THERE WAS NO KNOWN IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT AND NO MATERIAL RESIDUE REMAINED IN THE PATIENT, AND THERE IS NO COLLATERAL DAMAGE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23508308 ↗InjuryNov 10, 2025Device Remains Activated; Device Remains Activated
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE PERFORATOR BIT DIDN'T STOP IN SURGERY AS IT SHOULD BE. IT WAS ALSO REPORTED THAT THE PATIENT HAD A LITTLE HEMATOMA, BUT IN THE END EVERYTHING WENT FINE AND NO PROBLEMS AFTER. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT UNDERWENT A BRAIN BIOPSY THROUGH A BOREHOLE. A MEDTRONIC DISPOSABLE DRILL BIT WAS USED, WHICH SHOULD STOP AUTOMATICALLY AFTER GOING THROUGH THE SKULL AND LOSING RESISTANCE. HOWEVER, THIS DID NOT HAPPEN, AND THE DRILL CONTINUED TO ROTATE, ALSO DRILLING THE CORTEX AND CAUSING DAMAGE/LEAKAGE TO THE OUTERMOST LAYER OF THE PATIENT'S BRAIN. THE PATIENT WOKE UP FROM THE PROCEDURE WITHOUT ANY PROBLEMS AND UNDERWENT CT SCANS, WHICH SHOWED A SMALL HEMATOMA IN THE PATIENT. THE PRODUCT INFORMATION WAS WRITTEN DOWN, AND THE REPRESENTATIVE OF THE PRODUCT WILL BE INFORMED ABOUT THIS. ON FOLLOW UP IT WAS REPORTED THAT THE THERE WERE NO INTERVENTION PERFORMED, NO PRODUCT DAMAGE AND NO PROCEDURE DELAY, THE PROCEDURE COMPLETED NORMALLY.
Patient problems: Hematoma; Perforation
MAUDE report 23508236 ↗InjuryNov 4, 2025Device Remains Activated; Device Remains Activated
IT WAS REPORTED THAT DURING THE TREPANATION PROCEDURE, THE PERFORATOR FAILED TO DISENGAGE, RESULTING IN INJURY TO THE DURA MATER AND A CEREBRAL CONTUSION, AND THE QUALITY OF CARE DEGRADED. IT WAS ALSO REPORTED THAT THEY ADJUSTED THEIR SURGICAL PLAN AND APPROACHED THE LESION FROM ANOTHER ANGLE.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation; Spinal Cord Injury
MAUDE report 23462508 ↗InjuryOct 31, 2025Device Remains Activated; Device Remains Activated
IT WAS REPORTED THAT WITH A PERFORATOR PLUNGING WHILE DOING A BURR HOLE IN A DEEP BRAIN SIMULATION CASE LAST WEEK. IT WAS FINE FOR THE FIRST THEN PLUNGED AND TORE THE DURA ON THE SECOND ONE.
Patient problems: Perforation
MAUDE report 23437630 ↗MalfunctionOct 24, 2025Device Remains Activated; Device Remains Activated
IT WAS REPORTED THAT THE SAFETY STOP FAILED TO ENGAGE DURING USE OF TWO PERFORATOR BITS FROM DIFFERENT LOTS. A REPLACEMENT BIT WAS OPENED FOR THE SECOND BURR HOLE, WHICH REPORTEDLY EXPERIENCED THE SAME ISSUE. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23378865 ↗MalfunctionOct 24, 2025Device Remains Activated; Device Remains Activated
IT WAS REPORTED THAT THE SAFETY STOP FAILED TO ENGAGE DURING USE OF TWO PERFORATOR BITS FROM DIFFERENT LOTS. A REPLACEMENT BIT WAS OPENED FOR THE SECOND BURR HOLE, WHICH REPORTEDLY EXPERIENCED THE SAME ISSUE. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23378781 ↗
Other Micromar Indústria e Comércio Ltda products
All Micromar Indústria e Comércio Ltda devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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