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	12/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The deviations identified are not considered to have caused or contributed to the described event (slippage).Due to contamination of the internal components, the openlock mechanism is more difficult to lock than specified but can still be locked completely.The correct locking of the handle wheel can and should be verified by checking that it is locked correctly in accordance with the ifu specifications.It is also not assumed that the slight deviation in pin force (~ 1%) at the highest of the four measuring points contributed to the slippage.The maintenance interval for the torque screw has been exceeded; the deviation could not have remained undetected during the standard product inspection as part of the annual maintenance specified in the product ifu.Our experience is, that the pinning technique is a major factor in terms of the occurrence probability of slippages.We refer to our corresponding recommendations described the product's instruction manual (secure the patient's head to the skull clamp): "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.".
Event or Problem Description
Distributor informed us on january 9, that one of our products was involved in a case in which the patient sustained a laceration.

• 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
• MDR Report Key: 24267391
• Report Number: 3003923579-2026-00003
• Device Sequence Number: 10714415
• Product Code: HBL
• UDI-Device Identifier: 04250435506196
• UDI-Public: 04250435506196
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/05/2026
• Report Date (Section F): 01/09/2026

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: 01/14/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/09/2026
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/09/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/05/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown