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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is no apparent connection between the deviation detected in this investigation (loose threaded insert on the fixed arm) and the reported slippage.Any deviations due to non-compliance with the maintenance cycle specified in the ifu may remain undetected if inspection and maintenance are not carried out, therefore the reporting customer is advised of the importance of complying with the maintenance interval within this complaint correspondence.From our experience, pinning technique plays a significant role in slippage during skull fixation, so it cannot be excluded that the pinning of the patient's skull may not have been 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.".
Event or Problem Description
Customer informed us on december 26 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: 24158740
• Report Number: 3003923579-2026-00002
• Device Sequence Number: 15850537
• Product Code: HBL
• UDI-Device Identifier: 04250435506196
• UDI-Public: 04250435506196
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/23/2026
• Report Date (Section F): 12/26/2025

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: 01/13/2026
• Distributor Facility Aware Date: 12/26/2025
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/26/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/23/2026
• 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