MAUDE Adverse Event Report: BLACK FOREST MEDICAL GMBH DORO® SKULL CLAMP; DORO® QR3 SKULL CLAMP

Model Number	1001.001
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/15/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of writing, the device in question had not been received for examination, therefore no conclusive assessment of the incident described can be provided at this time.The reporting party has been requested to provide the product and additional information regarding the reported incident.Upon further inquiry, the reporting party communicated that the reported event is suspected to be caused by an unspecified "user mistake" and that a product return is not intended.Even though no serious injury occurred in this case, it was decided to report the incident due to the potential risk of injury.Further information was requested from the reporter.If any further relevant information will be received, it will be included in a follow-up report.
Event or Problem Description
Customer informed us that one of our products was involved in a case in which the patient's head fell from the skull clamp.

• Brand Name: DORO® SKULL CLAMP
• Common Device Name: DORO® QR3 SKULL CLAMP
• Manufacturer (Section D): BLACK FOREST MEDICAL GMBH; boetzinger strasse 86; freiburg im breisgau, baden-wuerttemberg 79111 ; GM 79111
• Manufacturer (Section G): BLACK FOREST MEDICAL GMBH; boetzinger strasse 86; freiburg im breisgau, baden-wuerttemberg 79111 ; GM 79111
• Manufacturer Contact: nicholas preissler ; boetzinger strasse 86; freiburg im breisgau, baden-wuerttemberg 79111 ; GM 79111
• MDR Report Key: 25559987
• Report Number: 3003923584-2026-00014
• Device Sequence Number: 10250019
• Product Code: HBL
• UDI-Device Identifier: 04250435506196
• UDI-Public: 04250435506196
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K203505
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1001.001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2026
• Initial Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown