DORO® Skull Clamp 4001-20Recalls & reported problems
Black Forest Medical GmbH · DORO® Skull Clamp Radiolucent (3-pin HFD) · Class 2
All models of DORO Skull Clamp (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04250435503867), received between Jan 14, 2020 and Jun 17, 2021 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Slipped” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K032331); 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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Device Slipped1
Patient problems
- Laceration(s)1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 17, 2021Adverse Event Without Identified Device or Use Problem
ALBERTA HEALTH SERVICES INFORMED OUR SERVICE DEPARTMENT ON 20TH OF MAY THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE WHERE A LACERATION OCCURED.
Patient problems: Laceration(s)
MAUDE report 12016104 ↗MalfunctionJan 14, 2020Device Slipped
CUSTOMER SERVICE WAS CONTACTED ON (B)(6) 2019 BY CUSTOMER. CUSTOMER STATED THAT THERE WAS SLIPPAGE DURING PRONE POSITIONING OF PATIENT. ANOTHER SKULL CLAMP WAS USED AND PROCEDURE WAS CONTINUED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9585946 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K032331. One submission often covers many models, so check the product and lot details in each record.
- Z-2972-2018 · Jul 5, 2018 · TerminatedDORO LUCENT Transitional Member, REF 1101.026 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries
- Z-2970-2018 · Jul 5, 2018 · TerminatedDORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percutaneous craniotomies and spinal surgeries
- Z-2971-2018 · Jul 5, 2018 · TerminatedDORO LUCENT Locking Transitional Member, REF 1101.031 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries
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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