DORO® Skull Clamp System 3020-00Recalls & reported problems
Black Forest Medical GmbH · DORO® Multi-Purpose Skull Clamp System, consisting of: 3006-10 3020-01 3020-03 3020-50 3020-55 3020-61 3020-62 3020-63 3020-65 3020-68 3020-71 3020-001 · Class 2
Data updated Oct 16, 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 04250435501573), received between Aug 26, 2020 and Aug 26, 2020 — classified as 1 injury.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Injury1
- Skin Discoloration1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 26, 2020Adverse Event Without Identified Device or Use Problem
QUALITY MANAGEMENT WAS CONTACTED ON 15TH OF JULY 2020 FROM CUSTOMER. CUSTOMER STATED A PRESSURE INJURY AND PINK SKIN RELATING TO THE USE OF A DORO® MULTI-PURPOSE SKULL CLAMP (SET).
Patient problems: Injury; Skin Discoloration
MAUDE report 10452777 ↗
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 13, 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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