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

Model Number	1001.001
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	03/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6), a customer informed us that one of our products was involved in an event in which a laceration occurred.
Additional Manufacturer Narrative
No findings were identified on the device submitted that could be causally or contributively related to the described slippage.The worn thread insert at the torque screw interface is typically caused by frequent use of a damaged counterpart (torque screw with a damaged threaded shaft) and/or insufficient lubrication of the feature.As the device did not show any deviation that could cause the reported incident, we suspect, that maybe the pinning technique has been not optimal as described in the instruction manual: "adjust the skull clamp to the width of the patient's head in the manner that the two skull pins in the rocker arm are equidistant from the centerline of the head and the single skull pin at the extension assembly is in line with this centerline.".

• 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: 24854608
• Report Number: 3003923584-2026-00012
• Device Sequence Number: 18764013
• Product Code: HBL
• UDI-Device Identifier: 04250435506196
• UDI-Public: 04250435506196
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 04/10/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2020
• 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