DORO® Skull Clamp 3003-009Recalls & reported problems
Black Forest Medical GmbH · DORO® QR3 Skull Clamp Teflon · Class 2
All models of DORO Skull Clamp (7)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DORO QR3 skull clamp is a surgical head holder used in brain surgery to keep the patient's head still. The 51 reports mostly describe the clamp slipping or shifting during use, with skin lacerations noted in 47 cases; there were 51 injuries and no deaths. 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
- 52
- Deaths reported
- 0
- Injuries reported
- 52
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 04250435500781), received between Sep 6, 2017 and Sep 3, 2026 — classified as 52 injuries.
The most frequently reported specific device problem is “Device Slipped” (45 reports).
2 other recalls cover devices cleared under the same FDA submission (K001808); they may or may not involve this specific model.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Slipped45
- Unintended Movement4
- Adverse Event Without Identified Device or Use Problem2
- Insufficient Device Problem Information1
Patient problems
- Laceration(s)48
- No Known Impact Or Consequence To Patient2
- No Consequences Or Impact To Patient1
- No Information1
Recent adverse event reports
The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.
InjurySep 3, 2026Device Slipped
Customer informed us on August 4, that one of our products was involved in a case in which the patient sustained a laceration.
Patient problems: Laceration(s)
MAUDE report 50586026 ↗InjuryMar 17, 2026Device Slipped
CUSTOMER INFORMED US THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE IN WHICH THE PATIENT SUSTAINED A LACERATION.
Patient problems: Laceration(s)
MAUDE report 24615052 ↗InjuryMar 17, 2026Device Slipped
CUSTOMER INFORMED US THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE IN WHICH THE PATIENT SUSTAINED A LACERATION.
Patient problems: Laceration(s)
MAUDE report 24615051 ↗InjuryDec 12, 2025Device Slipped; Device Slipped
DISTRIBUTOR INFORMED US ON NOVEMBER 28 THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE IN WHICH THE PATIENT SUSTAINED SKIN LACERATIONS.
Patient problems: Laceration(s)
MAUDE report 23787010 ↗InjuryAug 7, 2025Device Slipped; Device Slipped
CUSTOMER INFORMED US ON JULY 9 THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE IN WHICH THE PATIENT SUSTAINED A LACERATION.
Patient problems: Laceration(s)
MAUDE report 22735899 ↗InjuryAug 7, 2025Device Slipped; Device 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 22735892 ↗InjuryFeb 20, 2025Device Slipped; Device Slipped
CUSTOMER INFORMED US ON FEBRUARY 2 THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE IN WHICH A LACERATION OCCURED.
Patient problems: Laceration(s)
MAUDE report 21419972 ↗InjuryFeb 20, 2025Device Slipped; Device Slipped
CUSTOMER INFORMED US ON FEBRUARY 2 THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE IN WHICH A LACERATION OCCURED.
Patient problems: Laceration(s)
MAUDE report 21419723 ↗InjuryFeb 19, 2025Device Slipped; Device Slipped
CUSTOMER INFORMED US ON FEBRUARY 2 THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE IN WHICH A LACERATION OCCURED.
Patient problems: Laceration(s)
MAUDE report 21409514 ↗InjuryFeb 18, 2025Device Slipped; Device Slipped
CUSTOMER 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 21394602 ↗InjuryJan 15, 2025Device Slipped; Device Slipped
CUSTOMER INFORMED OUR SALES DEPARTMENT ON JANUARY 8 THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A PROCEDURE IN WHICH THE PATIENT SUSTAINED A LACERATION.
Patient problems: Laceration(s)
MAUDE report 21155729 ↗InjuryOct 2, 2024Device Slipped; Device Slipped
CUSTOMER INFORMED US ON SEPTEMBER 6, THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE (POSTERIOR CERVICAL), IN WHICH THE PATIENT SUSTAINED A LACERATION.
Patient problems: Laceration(s)
MAUDE report 20350579 ↗InjuryOct 2, 2024Device Slipped; Device Slipped
CUSTOMER INFORMED US ON SEPTEMBER 6, THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE (POSTERIOR CERVICAL), IN WHICH THE PATIENT SUSTAINED A LACERATION
Patient problems: Laceration(s)
MAUDE report 20350555 ↗InjuryAug 31, 2024Unintended Movement; Unintended Movement
CUSTOMER INFORMED US ON (B)(6) 2024 THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE (POSTERIOR CERVICAL, SUPINE POSITION) IN WHICH THE PATIENT SUSTAINED A LACERATION DURING REPOSITIONING FROM SUPINE TO PRONE.
Patient problems: Laceration(s)
MAUDE report 20114094 ↗InjuryAug 31, 2024Unintended Movement; Unintended Movement
CUSTOMER INFORMED US ON (B)(6)2024 THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE (POSTERIOR CERVICAL, SUPINE POSITION) IN WHICH THE PATIENT SUSTAINED A LACERATION DURING REPOSITIONING FROM SUPINE TO PRONE.
Patient problems: Laceration(s)
MAUDE report 20114093 ↗InjuryJul 5, 2024Device Slipped; Device Slipped
CUSTOMER INFORMED US THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE (POSTERIOR CRANIAL FUSION, PRONE POSITION) IN WHICH THE PATIENT SLIPPED OUT OF THE CLAMP AND SUSTAINED A LACERATION. TWO DIFFERENT SKULL CLAMPS (SAME ITEM-NO.) WERE RECEIVED FOR EXAMINATION. THE REPORTING CUSTOMER COULD NO LONGER STATE WITH SUFFICIENT CERTAINTY WHICH OF THE TWO PRODUCTS WAS INVOLVED IN THE EVENT DESCRIBED AND THEREFORE SENT BOTH PRODUCTS IN QUESTION FOR EXAMINATION.
Patient problems: Laceration(s)
MAUDE report 19679011 ↗InjuryJul 5, 2024Device Slipped; Device Slipped
CUSTOMER INFORMED US THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE (POSTERIOR CRANIAL FUSION, PRONE POSITION) IN WHICH THE PATIENT SLIPPED OUT OF THE CLAMP AND SUSTAINED A LACERATION. TWO DIFFERENT SKULL CLAMPS (SAME ITEM-NO.) WERE RECEIVED FOR EXAMINATION. THE REPORTING CUSTOMER COULD NO LONGER STATE WITH SUFFICIENT CERTAINTY WHICH OF THE TWO PRODUCTS WAS INVOLVED IN THE EVENT DESCRIBED AND THEREFORE SENT BOTH PRODUCTS IN QUESTION FOR EXAMINATION.
Patient problems: Laceration(s)
MAUDE report 19679010 ↗InjuryJun 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DISTRIBUTOR INFORMED US ON JUNE 10 THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A PROCEDURE (CRANIOTOMY IN SUPINE POSITION), IN WHICH THE PATIENT'S HEAD SLIPPED ON THE ONE-PIN SIDE RESULTING IN A LACERATION TO THE PATIENT.
Patient problems: Laceration(s)
MAUDE report 19593558 ↗InjuryMay 13, 2024Unintended Movement; Unintended Movement
DISTRIBUTOR INFORMED US ON APRIL 15 THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A PROCEDURE RESULTING IN A SLIPPAGE, IN WHICH THE TREATED PATIENT SUSTAINED A LACERATION.
Patient problems: Laceration(s)
MAUDE report 19297105 ↗InjuryApr 23, 2024Device Slipped; Device Slipped
CUSTOMER INFORMED US ON APRIL 12 THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE IN WHICH THE TREATED PATIENT SUSTAINED A LACERATION.
Patient problems: Laceration(s)
MAUDE report 19161619 ↗InjuryApr 23, 2024Device Slipped; Device Slipped
CUSTOMER INFORMED US ON APRIL 12 THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE IN WHICH THE TREATED PATIENT SUSTAINED A LACERATION.
Patient problems: Laceration(s)
MAUDE report 19161568 ↗InjuryApr 23, 2024Device Slipped; Device Slipped
CUSTOMER INFORMED US ON (B)(6) THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE IN WHICH THE TREATED PATIENT SUSTAINED A LACERATION.
Patient problems: Laceration(s)
MAUDE report 19161567 ↗InjuryMar 11, 2024Device Slipped; Device Slipped
CUSTOMER INFORMED US ON FEBRUARY 15 THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A PROCEDURE (POSTERIOR CRANIAL FUSION) RESULTING IN A SLIPPAGE, IN WHICH THE TREATED PATIENT SUSTAINED TWO LACERATIONS.
Patient problems: Laceration(s)
MAUDE report 18873067 ↗InjuryMar 11, 2024Device Slipped; Device Slipped
CUSTOMER INFORMED US ON FEBRUARY 15 THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A PROCEDURE (POSTERIOR CRANIAL FUSION) RESULTING IN A SLIPPAGE, IN WHICH THE TREATED PATIENT SUSTAINED TWO LACERATIONS.
Patient problems: Laceration(s)
MAUDE report 18873065 ↗InjuryFeb 21, 2024Device Slipped; Device Slipped
THE CUSTOMER INFORMED US ON (B)(6) THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A PROCEDURE IN WHICH THE PATIENT BEING TREATED SUSTAINED AN INJURY. THE RESPONSIBLE SALES REPRESENTATIVE INFORMED US THAT HE BELIEVED THE OCCURRED INJURY WAS A LACERATION. NO FURTHER INFORMATION WAS PROVIDED DESPITE FOLLOW-UP REQUESTS.
Patient problems: Laceration(s)
MAUDE report 18748364 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K001808. One submission often covers many models, so check the product and lot details in each record.
- Z-1860-2025 · Mar 14, 2025 · Open, ClassifiedDORO Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)
- Z-0193-2018 · Nov 2, 2017 · Terminatedpmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 pieces per blister, 12 blisters per box), STERILE R, Rx ONLY The DORO(R) Skull Pins are inserted into t
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® 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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