DORO® Skull Clamp 1001.001Recalls & reported problems
Black Forest Medical GmbH · DORO® QR3 Skull Clamp · Class 2
All models of DORO Skull Clamp (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DORO QR3 skull clamp from Black Forest Medical has 169 reports, with no deaths and 159 injuries. Reports mostly describe the clamp's pins slipping, which led to lacerations, and some describe a patient's head falling from the clamp. Some reports also list a skull fracture. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 173
- Deaths reported
- 0
- Injuries reported
- 163
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 173 adverse event reports that list this exact device (DI 04250435506196), received between Mar 6, 2017 and Sep 29, 2026 — classified as 163 injuries, 10 malfunctions.
The most frequently reported specific device problem is “Device Slipped” (128 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, 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.
Reports received per month
Most reported problems
Device problems
- Device Slipped128
- Adverse Event Without Identified Device or Use Problem17
- Use of Device Problem10
- Unintended Movement6
- Device Handling Problem5
- Insufficient Device Problem Information3
- Mechanical Problem2
- Compatibility Problem1
Patient problems
- Laceration(s)143
- No Clinical Signs, Symptoms or Conditions10
- Insufficient Information6
- No Known Impact Or Consequence To Patient4
- Skull Fracture4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- No Consequences Or Impact To Patient2
- Abrasion1
Recent adverse event reports
The 25 most recent of 173 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Device Slipped
Patient problems: Laceration(s)
MAUDE report 50927632 ↗InjurySep 24, 2026Device Slipped
Customer informed us, that one of our products was involved in a case in which the patient sustained a cut to the scalp.
Patient problems: Laceration(s)
MAUDE report 50881986 ↗InjurySep 24, 2026Device Slipped
Customer informed us, that one of our products was involved in a case in which the patient sustained a cut to the scalp.
Patient problems: Laceration(s)
MAUDE report 50881985 ↗InjuryAug 7, 2026Device Slipped
Customer informed us on July 22, that one of our products was involved in a case in which a laceration and CSF leakage occurred.
Patient problems: Cerebrospinal Fluid Leakage; Laceration(s)
MAUDE report 50169796 ↗InjuryJul 30, 2026Device Slipped
German authorities (BfArM) informed us on July 9 that one of our products was involved in a case in which the treated patient sustained bilateral head injuries at the contact points of the skull clamp.
Patient problems: Laceration(s)
MAUDE report 50081256 ↗InjuryJul 3, 2026Device Slipped
ON 18 JUNE, A CUSTOMER INFORMED US THAT ONE OF OUR PRODUCTS HAD BEEN INVOLVED IN AN INCIDENT RESULTING IN A LACERATION AND A SKULL FRACTURE.
Patient problems: Laceration(s)
MAUDE report 25703760 ↗InjuryJun 19, 2026Use of Device Problem
CUSTOMER INFORMED US THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE IN WHICH THE PATIENT'S HEAD FELL FROM THE SKULL CLAMP.
Patient problems: Insufficient Information
MAUDE report 25559987 ↗InjuryApr 13, 2026Device Slipped
ON (B)(6), A CUSTOMER INFORMED US THAT ONE OF OUR PRODUCTS WAS INVOLVED IN AN EVENT IN WHICH A LACERATION OCCURRED.
Patient problems: Laceration(s)
MAUDE report 24854608 ↗InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem
CUSTOMER INFORMED US ON MARCH 17 THAT ONE OF OUR PRODUCTS WAS INVOLVED IN AN INCIDENT THAT RESULTED IN A LACERATION.
Patient problems: Laceration(s)
MAUDE report 24647273 ↗InjuryMar 18, 2026Device Slipped
CUSTOMER INFORMED US THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE IN WHICH THE PATIENT SUSTAINED AN INJURY FROM PINS SLIPPING.
Patient problems: Insufficient Information
MAUDE report 24628950 ↗InjuryMar 18, 2026Device Slipped
CUSTOMER INFORMED US THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE IN WHICH THE PATIENT SUSTAINED AN INJURY FROM PINS SLIPPING.
Patient problems: Insufficient Information
MAUDE report 24625024 ↗InjuryMar 12, 2026Device Slipped
CUSTOMER INFORMED US ON 23RD OF FEBRUARY THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE IN WHICH A LACERATION OCCURED.
Patient problems: Laceration(s)
MAUDE report 24580179 ↗InjuryMar 12, 2026Device Slipped
CUSTOMER INFORMED US, ON 23RD OF FEBRUARY, THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE IN WHICH A LACERATION OCCURED.
Patient problems: Laceration(s)
MAUDE report 24577978 ↗InjuryFeb 13, 2026Device Slipped
CUSTOMER INFORMED US ON JANUARY 14 THAT ONE OF OUR PRODUCTS WAS INVOLVED IN AN INCIDENT THAT RESULTED IN A LACERATION.
Patient problems: Laceration(s)
MAUDE report 24332796 ↗InjuryFeb 13, 2026Device Slipped
CUSTOMER INFORMED US ON JANUARY 14 THAT ONE OF OUR PRODUCTS WAS INVOLVED IN AN INCIDENT THAT RESULTED IN A LACERATION.
Patient problems: Laceration(s)
MAUDE report 24332795 ↗InjuryFeb 5, 2026Device Slipped
DISTRIBUTOR INFORMED US ON JANUARY 9, THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE IN WHICH THE PATIENT SUSTAINED A LACERATION.
Patient problems: Laceration(s)
MAUDE report 24267393 ↗InjuryFeb 5, 2026Device Slipped
DISTRIBUTOR INFORMED US ON JANUARY 9, THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE IN WHICH THE PATIENT SUSTAINED A LACERATION.
Patient problems: Laceration(s)
MAUDE report 24267391 ↗MalfunctionFeb 3, 2026
SURGEON PLACED THE CLAMP ON THE PATIENT. THE PINS SLIPPED CAUSING A LACERATION. THE SURGEON PLACED STAPLES IN THE SKIN. RN TOOK THAT MAYFIELD OUT OF SERVICE, AND BROUGHT A DIFFERENT ONE IN THE ROOM.
Patient problems: Laceration(s)
MAUDE report 24245671 ↗InjuryJan 23, 2026Device Slipped
CUSTOMER INFORMED US ON (B)(6) THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE IN WHICH THE PATIENT SUSTAINED A LACERATION.
Patient problems: Laceration(s)
MAUDE report 24158741 ↗InjuryJan 23, 2026Device Slipped
CUSTOMER INFORMED US ON DECEMBER 26 THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE IN WHICH THE PATIENT SUSTAINED A LACERATION.
Patient problems: Laceration(s)
MAUDE report 24158740 ↗InjuryJan 14, 2026Device Slipped
CUSTOMER INFORMED US ON DECEMBER 12, 2025, THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE IN WHICH A LACERATION OCCURRED.
Patient problems: Laceration(s)
MAUDE report 24068528 ↗InjuryJan 8, 2026Device Slipped
DISTRIBUTOR INFORMED US ON DECEMBER 11 THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE IN WHICH THE TREATED PATIENT SUSTAINED A LACERATION.
Patient problems: Laceration(s)
MAUDE report 24001874 ↗InjuryDec 20, 2025Device Slipped; Device Slipped
DISTRIBUTOR INFORMED US ON DECEMBER 3 THAT AT LEAST ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE IN WHICH THE SKULL CLAMP "LOST TENSION RESULTING IN HEAD MOVEMENT AND LOSS OF STEALTH NAVIGATION".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23858573 ↗InjuryDec 20, 2025Device Slipped; Device Slipped
DISTRIBUTOR INFORMED US ON DECEMBER 3 THAT AT LEAST ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE IN WHICH THE PATIENT SUSTAINED A LACERATION.
Patient problems: Laceration(s)
MAUDE report 23858572 ↗InjuryDec 20, 2025Device Slipped; Device Slipped
DISTRIBUTOR INFORMED US ON DECEMBER 3 THAT AT LEAST ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE IN WHICH THE PATIENT SUSTAINED A LACERATION.
Patient problems: Laceration(s)
MAUDE report 23858571 ↗
Other Holder, Head, Neurosurgical (Skull Clamp) devices
- MAYFIELD® A1059Integra Lifesciences Corporation · HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)506 reports
- MAYFIELD® A3059Integra Lifesciences Corporation · HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)196 reports
- Head Fixation Device HFD100IMRIS Imaging, Inc. · Holder, Head, Neurosurgical (Skull Clamp)1 recall13 reports
- HFD100 119629-000IMRIS Imaging, Inc. · Holder, Head, Neurosurgical (Skull Clamp)1 recall6 reports
- DORO® Skull Clamp 3003-009Black Forest Medical GmbH · Holder, Head, Neurosurgical (Skull Clamp)52 reports
- DORO® Easy-Connect Navigation Adaptor 1204.002Black Forest Medical GmbH · Holder, Head, Neurosurgical (Skull Clamp)1 recall1 report
- HFD100 119695-000IMRIS Imaging, Inc. · Holder, Head, Neurosurgical (Skull Clamp)1 recall1 report
- HFD100 119630-000IMRIS Imaging, Inc. · Holder, Head, Neurosurgical (Skull Clamp)1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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