DORO LUCENT® Skull Clamp (1101.001)Recalls & reported problems
Black Forest Medical GmbH · DORO LUCENT® Skull Clamp · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04250435532355), received between Feb 18, 2026 and Feb 18, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Device Slipped” (1 report).
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 Slipped1
Patient problems
- Laceration(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 18, 2026Device Slipped
CUSTOMER (DISTRIBUTOR) INFORMED US THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE IN WHICH A LACERATION OCCURRED.
Patient problems: Laceration(s)
MAUDE report 24378535 ↗
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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