DORO® Skull Clamp 3020-50Recalls & reported problems
Black Forest Medical GmbH · DORO® QR3 Multi Purpose Skull Clamp · Class 2
All models of DORO Skull Clamp (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04250435501689), received between Nov 24, 2017 and Mar 20, 2026 — classified as 6 injuries, 1 malfunction.
The most frequently reported specific device problem is “Unintended Movement” (3 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Unintended Movement3
- Device Slipped2
- Adverse Event Without Identified Device or Use Problem1
- Device Handling Problem1
- Structural Problem1
- Use of Device Problem1
Patient problems
- Laceration(s)5
- Ecchymosis1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryMar 20, 2026Unintended Movement
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 24647294 ↗InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CUSTOMER INFORMED US ON (B)(6) THAT ONE OF OUR PRODUCTS WAS INVOVLED IN A CASE, IN WHICH THE TREATED PATIENT SUSTAINED A BEDSORE/ AN ESCHAR ON THE BACK OF THE SKULL.
Patient problems: Ecchymosis
MAUDE report 20350522 ↗InjuryOct 12, 2023Device Slipped; Device Slipped
CUSTOMER INFORMED US ON THE (B)(6) THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A PROCEDURE (4 PIN CONFIGURATION) IN WHICH A LACERATION OCCURED TO THE PATIENT.
Patient problems: Laceration(s)
MAUDE report 17918595 ↗InjuryOct 12, 2023Device Slipped; Device Slipped
CUSTOMER INFORMED US ON THE 14TH OF SEPTEMBER THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A PROCEDURE (4 PIN CONFIGURATION) IN WHICH A LACERATION OCCURED TO THE PATIENT.
Patient problems: Laceration(s)
MAUDE report 17918594 ↗InjuryJan 19, 2022Unintended Movement
CUSTOMER INFORMED OUR SERVICE DEPARTMENT ON THE (B)(6) THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE WHERE A SMALL LACERATION OCCURED.
Patient problems: Laceration(s)
MAUDE report 13288863 ↗InjuryFeb 27, 2019Use of Device Problem; Device Handling Problem; Use of Device Problem; Device Handling Problem
CUSTOMER SERVICE WAS CONTACTED BY CUSTOMER ON (B)(6) 2019. CUSTOMER STATED THAT THE SKULL CLAMP WAS INVOLVED IN A SLIPPAGE.
Patient problems: Laceration(s)
MAUDE report 8373134 ↗MalfunctionNov 24, 2017Structural Problem; Unintended Movement
ADDITIONALLY INFORMATION RECEIVED ON DECEMBER 12TH 2017: THE CLAMP WAS INCIDENTLY OPENED, DURING THE SURGERY SOMEONE REACHED THE KNOB OF THE RELEASE KNOB OF THE SKULL CLAMP, WHICH OPENED THE SKULL CLAMP. THE RISK WAS BEING SEEN IN THE HEAD BEING ABLE TO FALL DOWN TO THE METAL PARTS OF THE SKULL CLAMP.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7057672 ↗
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® 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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