DORO® Skull Clamp 3034-00Recalls & reported problems
Black Forest Medical GmbH · DORO® Skull Clamp Radiolucent · Class 2
All models of DORO Skull Clamp (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
The DORO Skull Clamp is a radiolucent head holder used to keep a patient's head steady during brain surgery. The 46 reports mostly describe the clamp slipping or shifting once it was in place, alongside skin cuts (lacerations), bruising and irritation. There are 45 injuries and no deaths; reports run from 2017 to early 2026, with 3 in the last 12 months versus 6 in the prior year. 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
- 46
- Deaths reported
- 0
- Injuries reported
- 45
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 04250435502181), received between Aug 31, 2017 and Feb 20, 2026 — classified as 45 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Slipped” (35 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 Slipped35
- Unintended Movement4
- Adverse Event Without Identified Device or Use Problem3
- Insufficient Device Problem Information2
- Break1
- Loose or Intermittent Connection1
- Noise, Audible1
- Pressure Problem1
Patient problems
- Laceration(s)39
- No Clinical Signs, Symptoms or Conditions2
- Bruise/Contusion1
- Injury1
- Insufficient Information1
- Irritation1
- No Consequences Or Impact To Patient1
- No Information1
Recent adverse event reports
The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.
InjuryFeb 20, 2026Device Slipped
CUSTOMER INFORMED US ON FEBRUARY 19 THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE IN WHICH A LACERATION OCCURRED.
Patient problems: Laceration(s)
MAUDE report 24399072 ↗InjuryJan 8, 2026Device Slipped
CUSTOMER INFORMED US ON DECEMBER 9 THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE IN WHICH A LACERATION OCCURRED.
Patient problems: Laceration(s)
MAUDE report 24001875 ↗InjuryJan 8, 2026Device Slipped
CUSTOMER INFORMED US ON DECEMBER 9 THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE IN WHICH A LACERATION OCCURRED.
Patient problems: Laceration(s)
MAUDE report 24001873 ↗InjuryJul 14, 2025Device Slipped; Device Slipped
CUSTOMER INFORMED OUR SALES MANAGER ON MAY 16 THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE IN WHICH THE PATIENT SUSTAINED A LACERATION.
Patient problems: Laceration(s)
MAUDE report 22493407 ↗InjuryJul 14, 2025Device Slipped; Device Slipped
CUSTOMER INFORMED OUR SALES MANAGER ON MAY 16 THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE IN WHICH THE PATIENT SUSTAINED A LACERATION.
Patient problems: Laceration(s)
MAUDE report 22493406 ↗InjuryFeb 21, 2025Device Slipped; Device Slipped
DISTRIBUTOR INFORMED US ON JANUARY 27 THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE IN WHICH A LACERATION OCCURED.
Patient problems: Laceration(s)
MAUDE report 21433781 ↗InjuryFeb 21, 2025Device Slipped; Device Slipped
DISTRIBUTOR INFORMED US ON JANUARY 27 THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE IN WHICH A LACERATION OCCURED.
Patient problems: Laceration(s)
MAUDE report 21433780 ↗InjuryFeb 21, 2025Device Slipped; Device Slipped
DISTRIBUTOR INFORMED US ON JANUARY 27 THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE IN WHICH A LACERATION OCCURED.
Patient problems: Laceration(s)
MAUDE report 21433779 ↗InjuryFeb 21, 2025Device Slipped; Device Slipped
DISTRIBUTOR INFORMED US ON (B)(6) THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE IN WHICH A LACERATION OCCURED.
Patient problems: Laceration(s)
MAUDE report 21433778 ↗InjuryMay 13, 2024Unintended Movement; Unintended Movement
DISTRIBUTOR INFORMED US ON APRIL 23 THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A PROCEDURE (CRANI AIRO CASE) IN WHICH THE TREATED PATIENT SUSTAINED A LACERATION.
Patient problems: Laceration(s)
MAUDE report 19297104 ↗InjuryMay 13, 2024Unintended Movement; Unintended Movement
DISTRIBUTOR INFORMED US ON APRIL 23 THAT ONE OF OUR PRODUCTS WAS INVOVLED IN A PROCEDURE (CRANI AIRO CASE) IN WHICH THE TREATED PATIENT SUSTAINED A LACERATION.
Patient problems: Laceration(s)
MAUDE report 19297103 ↗InjuryMar 28, 2024Device Slipped; Device Slipped
CUSTOMER INFORMED US ON MARCH 1 THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A PROCEDURE (CRANIOTOMY FOR ANEURYSM) IN WHICH THE TREATED PATIENT SUSTAINED A LACERATION.
Patient problems: Laceration(s)
MAUDE report 18991180 ↗InjuryMar 28, 2024Device Slipped; Device Slipped
CUSTOMER INFORMED US ON MARCH 1 THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A PROCEDURE (CRANIOTOMY FOR ANEURYSM) IN WHICH THE TREATED PATIENT SUSTAINED A LACERATION.
Patient problems: Laceration(s)
MAUDE report 18991168 ↗InjuryMar 25, 2024Device Slipped; Device Slipped
DISTRIBUTOR INFORMED US ON MARCH 18 THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A PROCEDURE (SUBOCCIPITAL CRANI RESECTION ARTERIOVENOUS MALFORMATION) IN WHICH THE TREATED PATIENT SUSTAINED A LACERATION.
Patient problems: Laceration(s)
MAUDE report 18968588 ↗InjuryMar 25, 2024Device Slipped; Device Slipped
DISTRIBUTOR INFORMED US ON MARCH 18 THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A PROCEDURE (SUBOCCIPITAL CRANI RESECTION ARTERIOVENOUS MALFORMATION) IN WHICH THE TREATED PATIENT SUSTAINED A LACERATION.
Patient problems: Laceration(s)
MAUDE report 18968587 ↗InjuryMar 25, 2024Device Slipped; Device Slipped
CUSTOMER INFORMED US ON MARCH 11 THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE (POSTERIOR CERVICAL) IN WHICH THE TREATED PATIENT SUSTAINED A LACERATION.
Patient problems: Laceration(s)
MAUDE report 18967680 ↗InjuryMar 25, 2024Device Slipped; Device Slipped
CUSTOMER INFORMED US ON MARCH 11 THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE (POSTERIOR CERVICAL) IN WHICH THE TREATED PATIENT SUSTAINED A LACERATION.
Patient problems: Laceration(s)
MAUDE report 18967679 ↗InjuryFeb 22, 2024Device Slipped; Device Slipped
CUSTOMER INFORMED US ON (B)(6) THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A PROCEDURE (POSTERIOR CRANIAL FUSION, PRONE POSITION) IN WHICH THE TREATED PATIENT SUSTAINED A SUPERFICIAL LACERATION.
Patient problems: Laceration(s)
MAUDE report 18756245 ↗InjuryFeb 22, 2024Device Slipped; Device Slipped
CUSTOMER INFORMED US ON JANUARY 31 THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A PROCEDURE (POSTERIOR CRANIAL FUSION, PRONE POSITION) IN WHICH THE TREATED PATIENT SUSTAINED A SUPERFICIAL LACERATION.
Patient problems: Laceration(s)
MAUDE report 18756244 ↗InjuryJun 29, 2023Device Slipped; Device Slipped
A CUSTOMER INFORMED US ON (B)(6) THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A SURGERY (VENTRICULOPERITONEAL SHUNT) IN WHICH THE PATIENT'S HEAD FELL OUT OF THE CLAMP AND THE PATIENT SUSTAINED SUPERFICIAL LACERATIONS.
Patient problems: Laceration(s)
MAUDE report 17225129 ↗InjuryJun 29, 2023Device Slipped; Device Slipped
A CUSTOMER INFORMED US ON THE 31TH OF MAY THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A SURGERY (VENTRICULOPERITONEAL SHUNT) IN WHICH THE PATIENT'S HEAD FELL OUT OF THE CLAMP AND THE PATIENT SUSTAINED SUPERFICIAL LACERATIONS.
Patient problems: Laceration(s)
MAUDE report 17225115 ↗InjuryApr 14, 2023Device Slipped; Device Slipped
DISTRIBUTOR INFORMED OUR SERVICE DEPARTMENT ON THE 24TH OF MARCH THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE WHERE A LACERATION OCCURED.
Patient problems: Laceration(s)
MAUDE report 16741687 ↗InjuryApr 14, 2023Device Slipped; Device Slipped
DISTRIBUTOR INFORMED OUR SERVICE DEPARTMENT ON THE 24TH OF MARCH THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE WHERE A LACERATION OCCURED.
Patient problems: Laceration(s)
MAUDE report 16741683 ↗InjuryMar 23, 2023Device Slipped; Device Slipped
CUSTOMER INFORMED OUR SERVICE DEPARTMENT ON THE 24TH OF FEBRUARY THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE WHERE ALACERATION OCCURED.
Patient problems: Laceration(s)
MAUDE report 16599806 ↗InjuryMar 23, 2023Device Slipped; Device Slipped
CUSTOMER INFORMED OUR SERVICE DEPARTMENT ON THE 24TH OF FEBRUARY THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE WHERE A LACERATION OCCURED.
Patient problems: Laceration(s)
MAUDE report 16599805 ↗
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
- DORO® Skull Clamp 1001.001Black Forest Medical GmbH · Holder, Head, Neurosurgical (Skull Clamp)173 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
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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