DORO Skull ClampRecalls & reported problems across all models
Black Forest Medical GmbH · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 283
- Deaths reported
- 0
- Injuries reported
- 269
- Recalls
- 0
We found 7 models of DORO Skull Clamp by Black Forest Medical GmbH in the FDA's device registry (GUDID). Together they are named in 283 adverse event reports in the FDA's MAUDE database, received between Mar 6, 2017 and Sep 29, 2026 — classified as 269 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Device Slipped” (213 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported DORO Skull Clamp problems
Device problems
- Device Slipped213
- Adverse Event Without Identified Device or Use Problem25
- Unintended Movement17
- Use of Device Problem11
- Device Handling Problem6
- Insufficient Device Problem Information6
- Loose or Intermittent Connection2
- Mechanical Problem2
Patient problems
- Laceration(s)237
- No Clinical Signs, Symptoms or Conditions12
- No Known Impact Or Consequence To Patient10
- Insufficient Information7
- No Consequences Or Impact To Patient4
- Skull Fracture4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Bruise/Contusion2
DORO Skull Clamp models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- DORO® Skull Clamp 1001.001Holder, Head, Neurosurgical (Skull Clamp)173 reports
- DORO® Skull Clamp 3003-009Holder, Head, Neurosurgical (Skull Clamp)52 reports
- DORO® Skull Clamp 3034-00Holder, Head, Neurosurgical (Skull Clamp)46 reports
- DORO® Skull Clamp 3020-50Holder, Head, Neurosurgical (Skull Clamp)7 reports
- DORO® Skull Clamp 3003-00Holder, Head, Neurosurgical (Skull Clamp)2 reports
- DORO® Skull Clamp 4001-20Holder, Head, Neurosurgical (Skull Clamp)2 reports
- DORO® Skull Clamp 4003.001Holder, Head, Neurosurgical (Skull Clamp)1 report
Recent DORO Skull Clamp adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Device Slipped
Patient problems: Laceration(s)
MAUDE report 50927632 ↗InjurySep 24, 2026Device Slipped
Customer informed us, that one of our products was involved in a case in which the patient sustained a cut to the scalp.
Patient problems: Laceration(s)
MAUDE report 50881986 ↗InjurySep 24, 2026Device Slipped
Customer informed us, that one of our products was involved in a case in which the patient sustained a cut to the scalp.
Patient problems: Laceration(s)
MAUDE report 50881985 ↗InjurySep 3, 2026Device Slipped
Customer informed us on August 4, that one of our products was involved in a case in which the patient sustained a laceration.
Patient problems: Laceration(s)
MAUDE report 50586026 ↗InjuryAug 7, 2026Device Slipped
Customer informed us on July 22, that one of our products was involved in a case in which a laceration and CSF leakage occurred.
Patient problems: Cerebrospinal Fluid Leakage; Laceration(s)
MAUDE report 50169796 ↗InjuryJul 30, 2026Device Slipped
German authorities (BfArM) informed us on July 9 that one of our products was involved in a case in which the treated patient sustained bilateral head injuries at the contact points of the skull clamp.
Patient problems: Laceration(s)
MAUDE report 50081256 ↗InjuryJul 3, 2026Device Slipped
ON 18 JUNE, A CUSTOMER INFORMED US THAT ONE OF OUR PRODUCTS HAD BEEN INVOLVED IN AN INCIDENT RESULTING IN A LACERATION AND A SKULL FRACTURE.
Patient problems: Laceration(s)
MAUDE report 25703760 ↗InjuryJun 19, 2026Use of Device Problem
CUSTOMER INFORMED US THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE IN WHICH THE PATIENT'S HEAD FELL FROM THE SKULL CLAMP.
Patient problems: Insufficient Information
MAUDE report 25559987 ↗InjuryApr 13, 2026Device Slipped
ON (B)(6), A CUSTOMER INFORMED US THAT ONE OF OUR PRODUCTS WAS INVOLVED IN AN EVENT IN WHICH A LACERATION OCCURRED.
Patient problems: Laceration(s)
MAUDE report 24854608 ↗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 ↗InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem
CUSTOMER INFORMED US ON MARCH 17 THAT ONE OF OUR PRODUCTS WAS INVOLVED IN AN INCIDENT THAT RESULTED IN A LACERATION.
Patient problems: Laceration(s)
MAUDE report 24647273 ↗InjuryMar 18, 2026Device Slipped
CUSTOMER INFORMED US THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE IN WHICH THE PATIENT SUSTAINED AN INJURY FROM PINS SLIPPING.
Patient problems: Insufficient Information
MAUDE report 24628950 ↗InjuryMar 18, 2026Device Slipped
CUSTOMER INFORMED US THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE IN WHICH THE PATIENT SUSTAINED AN INJURY FROM PINS SLIPPING.
Patient problems: Insufficient Information
MAUDE report 24625024 ↗InjuryMar 17, 2026Device Slipped
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 24615052 ↗InjuryMar 17, 2026Device Slipped
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 24615051 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page