MIDS REX MR8Recalls & reported problems across all models
Medtronic Powered Surgical Solutions · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 9 models of MIDS REX MR8 by Medtronic Powered Surgical Solutions in the FDA's device registry (GUDID). Together they are named in 26 adverse event reports in the FDA's MAUDE database, received between May 11, 2023 and Sep 28, 2026 — classified as 3 injuries, 23 malfunctions.
The most frequently reported specific device problem is “Fracture” (23 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 MIDS REX MR8 problems
Device problems
- Fracture23
- No Apparent Adverse Event4
- Overheating of Device3
- Dull, Blunt2
- Noise, Audible1
- Unintended System Motion1
Patient problems
- No Clinical Signs, Symptoms or Conditions23
- Unintended Radiation Exposure2
- Cerebrospinal Fluid Leakage1
- Device Embedded In Tissue or Plaque1
- Dural Tear1
- Hydrocephalus1
- Hypovolemia1
- Insufficient Information1
MIDS REX MR8 models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MIDS REX MR8 MR8-10BA40DDRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)8 reports
- MIDS REX MR8 MR8-10BA50DXDRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)8 reports
- MIDS REX MR8 MR8-10BA20DDRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)3 reports
- MIDS REX MR8 MR8-10BA60DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)2 reports
- MIDS REX MR8 MR8-10BA20DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)1 report
- MIDS REX MR8 MR8-10BA30DDRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)1 report
- MIDS REX MR8 MR8-10BA30DCDRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)1 report
- MIDS REX MR8 MR8-10BA50DDRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)1 report
- MIDS REX MR8 MR8-10MH22DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)1 report
Recent MIDS REX MR8 adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Unintended System Motion
It was reported that, during a surgical procedure, decompression was performed under general anesthesia at L2/3 on the right, with c ontralateral over-the-top decompression on the left, as well as left-sided decompression at L4/5. During the L2/3 decompression, the drill unexpectedly became blocked and subsequently malfunctioned. At the same time, the patient made a sudden and forceful movement of the lower limb despite general anesthesia. Microscopic inspection revealed a focal dural opening adjacent to the right L3 nerve root with low-volume CSF leakage. An intraoperative nerve root injury was suspected. The decompression was carefully continued, andthe right L3 nerve root and contralateral spinal canal were adequately decompressed. The dural opening was treated locally with TachoSil. Hemostasis was achieved, and a Valsalva maneuver at the end of the repair showed no persistent CSF leakage. Additional information was received from the surgeon clarified that the instrument remained securely held, but the burr attachment suddenly thrust forward while operating at full speed. The event occurred within milliseconds without warning, and the exact mechanism could not beconfirmed retros
Patient problems: Cerebrospinal Fluid Leakage; Dural Tear; Hydrocephalus; Hypovolemia
MAUDE report 50916753 ↗MalfunctionSep 10, 2026Fracture
It was reported that during preoperative attachment installation for pituitary lesion resection, the drill bit fractured and could not be used. The physician replaced it with a new product, and the operation was completed. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50712808 ↗MalfunctionApr 14, 2026Fracture
IT WAS REPORTED THAT DURING THE PROCEDURE, THE CUTTER FRACTURED AT THE JUNCTION BETWEEN THE SHANK AND THE BALL. THIS RAISED A SIGNIFICANT RISK OF BREACH AND POTENTIAL LOSS OF THE BUR TIP INTO THE SPINAL CANAL. HOWEVER, ADDITIONAL INFORMATION INDICATED THAT THE FRAGMENT WAS RETRIEVED WITH PLIERS WITHIN FIVE MINUTES, AND THERE WAS NO IMPACT ON THE PATIENT. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED WITH THE ADDITIONAL DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24869736 ↗MalfunctionFeb 11, 2026Fracture
IT WAS REPORTED THAT DURING THE PROCEDURE BUR WAS BROKEN. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCTS AND THERE IS NO BROKEN PIECES REMAIN INSIDE THE PATIENT'S BODY. IT WAS ALSO REPORTED THAT THERE WAS NO ANY ADDITIONAL INTERVENTION PERFORMED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO PATIENT OR STAFF IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24311045 ↗MalfunctionJan 21, 2026Fracture
IT WAS REPORTED THAT DURING ENDOSCOPIC TRANSSPHENOIDAL RESECTION OF A PITUITARY TUMOR, THE BURR HEAD FRACTURED, RENDERING THE DEVICE UNUSABLE. IT WAS ALSO REPORTED THAT THERE IS A 5 MINUTES OF SURGICAL DELAY AND THE PROCEDURE COMPLETED WITH BACKUP PRODUCTS. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24127623 ↗MalfunctionNov 19, 2025Overheating of Device; Dull, Blunt; Overheating of Device; Dull, Blunt
IT WAS REPORTED THAT IN THE SHORT TIME ABOUT 50 SECONDS, BOTH DRILLS WERE NO LONGER ABLE TO MILL THE BONE, AND THEY TENDED TO BURN THE MILLED PART. THERE WAS NO PATIENT INVOLVED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23601286 ↗MalfunctionNov 19, 2025Overheating of Device; Dull, Blunt; Overheating of Device; Dull, Blunt
IT WAS REPORTED THAT IN THE SHORT TIME ABOUT 50 SECONDS, BOTH DRILLS WERE NO LONGER ABLE TO MILL THE BONE, AND THEY TENDED TO BURN THE MILLED PART. THERE WAS NO PATIENT INVOLVED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23601275 ↗MalfunctionNov 18, 2025Fracture; No Apparent Adverse Event; Fracture; No Apparent Adverse Event
IT WAS REPORTED THAT DURING A POSTERIOR CERVICAL SPINE DECOMPRESSION AND FIXATION PROCEDURE, A MATCHHEAD TOOL FRACTURED WHILE CREATING A PILOT HOLE FOR A CERVICAL PEDICLE SCREW USING THE MOTOR. THE PATIENT¿S BONE WAS REPORTED TO BE SCLEROTIC, AND INCREASED FORCE WAS APPLIED AS THE SHAFT WAS THICKER THAN THE TIP BALL DIAMETER (2 MM). THE PROCEDURE WAS COMPLETED USING A SPARE PRODUCT. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23578604 ↗MalfunctionOct 22, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A SPINAL SURGERY, THE TOOL FRACTURED WHILE IN USE. THE PROCEDURE WAS COMPLETED USING A BACKUP PRODUCT WITHOUT ANY REPORTED DELAY. THERE WAS NO REPORTED PATIENT INJURY OR IMPACT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23356342 ↗MalfunctionAug 6, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING SPINAL RECALIBRATION TOOL BROKE. IT WAS REPORTED THAT THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN END FROM THE PATIENT'S BONE AND THERE WAS A DELAY OF TEN MINUTES IN PROCEDURE AS A RESULT OF THE EVENT. THE PROCEDURE WAS COMPLETED WITH THE BACKUP PRODUCTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22725154 ↗MalfunctionJul 1, 2025Fracture; Fracture
IT WAS REPORTED THAT BURR BROKE. NO PATIENT IMPACT REPORTED.ON FOLLOW UP, IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22373993 ↗MalfunctionApr 18, 2025Fracture; No Apparent Adverse Event; Fracture; No Apparent Adverse Event
REPAIR REQUEST INITIATED FOR DEVICE WITH NO REPORTED MALFUNCTION. NO PATIENT IMPACT REPORTED. REPAIR ESCALATED TO PRODUCT EVENT ON EVALUATION DUE TO BEARING DETACHMENT AND DISSECTING TOOL.
Patient problems: Insufficient Information
MAUDE report 21863030 ↗MalfunctionApr 1, 2025Fracture; No Apparent Adverse Event; Fracture; No Apparent Adverse Event
IT WAS REPORTED THAT TOOL BROKEN DURING PROCEDURE. IT WAS ALSO REPORTED THAT THERE WAS NO PATEINT OR STAFF IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21736092 ↗MalfunctionMar 31, 2025Fracture; Fracture
IT WAS REPORTED THAT TIP OF DRILL BROKEN DURING THE USE AND THE PROCEDURE WAS COMPLETED WITH THE BACKUP PRODUCT. IT WAS REPORTED THAT THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT AND THERE WAS DELAY IN PROCEDURE FOR TWO MINUTES. NO ADDITIONAL INTERVENTION WAS PERFORMED OR PLANNED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21735836 ↗MalfunctionMar 31, 2025Fracture; Fracture
IT WAS REPORTED THAT INTRA-OP LUMBAR FUSION, TOOL BROKE. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. THERE WAS DELAY OF LESS THAN AN HOUR AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21734059 ↗
Other Medtronic Powered Surgical Solutions products
All Medtronic Powered Surgical Solutions 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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