DORO® Adaptor 3002-50Recalls & reported problems
Black Forest Medical GmbH · DORO® Ball Pivot Adaptor · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04250435500668), received between Aug 26, 2020 and Aug 26, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Slipped” (2 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Device Slipped2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 26, 2020Device Slipped
CUSTOMER SERVICE WAS CONTACTED ON (B)(6) 2020 FROM CUSTOMER. CUSTOMER STATED THAT A SLIPPAGE OF A BALL PIVOT ADAPTER DURING PROCEDURE OCCURRED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10452782 ↗InjuryAug 26, 2020Device Slipped
CUSTOMER SERVICE WAS CONTACTED ON (B)(6) 2020 FROM CUSTOMER. CUSTOMER STATED THAT A SLIPPAGE OF A BALL PIVOT ADAPTER DURING PROCEDURE OCCURRED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10452781 ↗
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
- HFD100 119695-000IMRIS Imaging, Inc. · Holder, Head, Neurosurgical (Skull Clamp)1 recall1 report
- DORO® Easy-Connect Navigation Adaptor 1204.002Black Forest Medical GmbH · Holder, Head, Neurosurgical (Skull Clamp)1 recall1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.