EasyDrill Cranial Perforator Ø14 x Ø11 x 1,5mmRecalls & reported problems across all models
Micromar Indústria e Comércio Ltda · 4 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 28
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls
- 0
We found 4 models of EasyDrill Cranial Perforator Ø14 x Ø11 x 1,5mm by Micromar Indústria e Comércio Ltda in the FDA's device registry (GUDID). Together they are named in 28 adverse event reports in the FDA's MAUDE database, received between Jan 16, 2019 and Dec 22, 2025 — classified as 15 injuries, 13 malfunctions.
The most frequently reported specific device problem is “Device Remains Activated” (25 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 1,5mm problems
Device problems
- Device Remains Activated25
- Fracture3
- Detachment of Device or Device Component1
- No Apparent Adverse Event1
Patient problems
- Perforation15
- No Clinical Signs, Symptoms or Conditions13
- Hemorrhage/Blood Loss/Bleeding2
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
- Spinal Cord Injury1
- Unspecified Tissue Injury1
EasyDrill Cranial Perforator Ø14 x Ø11 x 1,5mm models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EasyDrill Cranial Perforator Ø14 x Ø11 x 1,5mm DM0210FAADrills, Burrs, Trephines & Accessories (Compound, Powered)14 reports
- EasyDrill Cranial Perforator Ø14 x Ø11 x 1,5mm DM0210FAADrills, Burrs, Trephines & Accessories (Compound, Powered)9 reports
- EasyDrill Cranial Perforator Ø14 x Ø11 x 1,5mm DM0210FAADrills, Burrs, Trephines & Accessories (Compound, Powered)3 reports
- EasyDrill Cranial Perforator Ø14 x Ø11 x 1,5mm DM0210FAADrills, Burrs, Trephines & Accessories (Compound, Powered)2 reports
Recent EasyDrill Cranial Perforator Ø14 x Ø11 x 1,5mm adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryDec 22, 2025Device Remains Activated; Device Remains Activated
IT WAS REPORTED THAT IN OPEN CRANIOTOMY PROCEDURE TO REMOVE BRAIN TUMOR THE BIT DID NOT STOP AUTOMATICALLY AND TORE THE PATIENT'S DURA MATER.THE PROCEDURE WAS EXTENDED FOR 5 MINUTES AND IT WAS COMPLETED BY THE BACKUP PRODUCTS.
Patient problems: Perforation
MAUDE report 23861727 ↗MalfunctionDec 19, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A BURR HOLE PROCEDURE, THREE PERFORATOR 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 23847016 ↗MalfunctionDec 19, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A BURR HOLE PROCEDURE, THREE PERFORATOR 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 23847014 ↗MalfunctionOct 22, 2025Device Remains Activated; Device Remains Activated
IT WAS REPORTED THAT DURING A CRANIOTOMY PROCEDURE, THE PERFORATOR WAS USED WITH THE MIDAS REX MOTOR TO DRILL INTO THE CRANIAL BONE. THE SURGEON OBSERVED THAT THE BURR DID NOT STOP ROTATING AFTER COMPLETING THE BONE PERFORATION. IT WAS ALSO REPORTED THAT NO INTERVENTION WAS PERFORMED AND THE PROCEDURE WAS COMPLETED USING THE SAME PRODUCT. IT WAS ALSO REPORTED THAT THERE WAS NO PROCEDURE DELAY AND NO PATIENT INJURY. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO PATIENT OR STAFF IMPACT AND THE RIGHT PARIETAL BONE OF THE SKULL WAS THE PERFORATED. IT WAS ALSO STATED THAT THE PATIENT HAVE RELEVANT NO BONE DISEASE OR COMORBIDITIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23356587 ↗MalfunctionMar 12, 2025Device Remains Activated; Device Remains Activated
IT WAS REPORTED THAT DURING A STANDARD TUMOR RESECTION PROCEDURE, FAILURE OF EASY DRILL PERFORATOR. IT WAS REPORTED THAT THE PATIENT WAS ALIVE WITH NO INJURY. IT WAS ALSO REPORTED THAT THERE WAS NO INTERVENTION PLANNED. ON FOLLOW-UP IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT AND THERE WAS NO DELAY IN PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21583858 ↗MalfunctionMar 4, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PROCEDURE TO PERFORATE THE SKULL TO RESECT THE TUMOR THE PRODUCT GOT BROKEN AND THE UPPER PART FELL OFF FROM THE DEVICE. IT WAS ALSO REPORTED THAT THERE WAS NO INTERVENTION PERFORMED AND THERE WAS NO DELAY IN PROCEDURE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. ADDITIONAL INFORMATION REGARDING THE PATIENT IMPACT WAS BEING FOLLOWED UP FROM THE FACILITY. ON ADDITIONAL FOLLOW THE PATIENT SHOWED NO SIGNS OF BONE DISEASES. THE SURGERY WAS PERFORMED DUE TO A HEMATOMA IN THE PARIETAL BONE AREA. TWO HOLES WERE CREATED USING A PERFORATOR, BUT THE DEVICE ENCOUNTERED AN ISSUE WITH THE FIRST HOLE. THE EM200 MOTOR WAS USED DURING THE PROCEDURE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21515466 ↗MalfunctionDec 3, 2024Device Remains Activated; Device Remains Activated
IT WAS REPORTED THAT DURING SHUNT INSERTION UNDER LAPAROSCOPY NAVIGATION, THE PERFORATOR DID NOT STOP WHILE DRILLING THROUGH THE SKULL BONE. IT WAS REPORTED THAT THE PATIENT WAS ALIVE - NO INJURY AND THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. UPON FOLLOWUP IT WAS CONFIRMED THAT THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20835852 ↗MalfunctionDec 1, 2024Device Remains Activated; Device Remains Activated
IT WAS REPORTED THAT IN THE PROCEDURE OF CRANIOTOMY THE DRILL DOESN'T MAKE CORRECT TURNS . IT STOPS FOR A WHILE THEN TURNS BACK ON. IT WAS REPORTED THAT INTERVENTION HAS BEEN PERFORMED. THE PROCEDURE WAS COMPLETED WITH THE BACKUP PRODUCT. UPON FOLLOWUP IT WAS CONFIRMED THAT THERE WAS NO PATIENT IMPACT. THERE WAS A DELAY FOR 30 MINUTES DURING THE PROCEDURE. NO INTERVENTION PERFORMED OR PLANNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20814364 ↗InjuryNov 4, 2024Device Remains Activated; Device Remains Activated
IT WAS REPORTED THAT WHEN DRILLING BURR HOLE, THE PERFORATOR DID NOT STOP AUTOMATICALLY WHEN FINISHED DRILLING BONE CONTINUING TO DRILL AND TEAR DURA MATER. IT WAS ALSO REPORTED THAT THERE WAS A PROCEDURE DELAY OF 30 MINUTES AND DURAL REPAIR WAS REQUIRED. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT.
Patient problems: Perforation
MAUDE report 20597442 ↗InjuryMay 12, 2022Device Remains Activated; Device Remains Activated
IT WAS REPORTED THAT THE PERFORATOR DID NOT STOP WHEN IT HIT THE BONE AND DAMAGED THE DURA. IT WAS REPORTED THAT THERE WAS SMALL AMOUNT OF BLEEDING AS A RESULT OF THIS EVENT AND THERE WAS A PROCEDURE DELAY OF 2 MINUTES TO STOP THE BLEEDING. DURING THE DELAY SURGEON DID COAGULATION WITH THE BIPOLAR CAUTERY.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation; Spinal Cord Injury
MAUDE report 14377987 ↗InjuryApr 26, 2022Device Remains Activated; Device Remains Activated
IT WAS REPORTED THAT WHEN USING PERFORATOR TO DRILL BURR HOLE INTO SKULL, IT CUT THROUGH SO QUICKLY AND CUT STRAIGHT THROUGH DURA AND THE CLUTCH MECHANISM DID NOT ACTIVATE. IT WAS REPORTED THAT THERE WAS DURA TEAR OF THE PATIENT BUT THERE WAS NO INTERVENTION PERFORMED. THE REST OF THE PROCEDURE WAS CARRIED OUT WITH THE HELP OF BACK UP DEVICE. THERE WAS NO DELAY IN PROCEDURE AS A RESULT OF THIS EVENT.
Patient problems: Perforation
MAUDE report 14210559 ↗MalfunctionAug 10, 2021Device Remains Activated; Device Remains Activated
IT WAS REPORTED THAT DURING A CRANIOTOMY PROCEDURE FOR A SUBDURAL HEMATOMA OF A TRAUMA PATIENT, THE PERFORATOR DID NOT STOP. IT WAS REPORTED THAT THERE WAS NO ADDITIONAL INTERVENTION PERFORMED AND THE PROCEDURE WAS COMPLETED USING A COMPETITIVE PERFORATOR. ON FOLLOW-UP, IT WAS REPORTED THAT THERE WAS A SHORT DELAY (LESS THAN 3 MINUTES) DUE TO RETRIEVAL AND PREPARATION OF A CODMAN PERFORATOR TO COMPLETE THE PROCEDURE. IT WAS ALSO CONFIRMED THAT THERE WAS NO PATIENT OR STAFF IMPACT AND THERE WAS NO FURTHER INFORMATION THAT CAN BE PROVIDED REGARDING THE STATUS OF THE PATIENT POST-SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12304344 ↗InjuryAug 3, 2021Device Remains Activated; Device Remains Activated
ON FURTHER FOLLOW UP IT WAS REPORTED THAT PROCEDURE IS CRANIOTOMY AND THEY NEED TO REPAIR DURA AND SOME DAMAGE IN TISSUE DURING THE DELAY.
Patient problems: Perforation; Unspecified Tissue Injury
MAUDE report 12270680 ↗InjuryJul 30, 2021Device Remains Activated; Device Remains Activated
ON FOLLOW-UP, IT WAS REPORTED THAT THERE WAS NO FURTHER INFORMATION THAT CAN BE PROVIDED REGARDING THE SERIAL NUMBERS OF THE EM200 AND AD03. IT WAS ALSO REPORTED THAT THE EM200 AND AD03 WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Perforation
MAUDE report 12257012 ↗InjuryJun 10, 2021Device Remains Activated; Device Remains Activated
IT WAS REPORTED THAT WHILE DRILLING FOR A BUR HOLE, THE PERFORATOR DID NOT STOP AND TEAR THE DURA. IT WAS ALSO REPORTED THAT THERE WAS NO PROCEDURE DELAY AND THE PROCEDURE WAS COMPLETED USING THE REPORTED PRODUCT. ON FOLLOW-UP, IT WAS CONFIRMED THAT THE PATIENT HAD NO FURTHER ISSUES POST-SURGERY.
Patient problems: Perforation
MAUDE report 11980002 ↗
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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