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	08/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer informed us, that one of our products was involved in a case in which the patient sustained a cut to the scalp.
Additional Manufacturer Narrative
Based on the findings of the investigation, the deviation identified (stiffness of the two-pin holder) presumably did not cause or contribute to the described incident.The skull clamp sent in was combined with a torque screw from a third-party manufacturer.It is therefore not possible to verify the conformity of the third-party product (clamping force verification).Risks due to impermissible combinations (third party torque screw) cannot be ruled out as a contributing factor to adverse events such as a loss of clamping force.In addition, the customer informed us, that the doctor may not have locked the open/lock-mechanism of the clamp properly.The customer is referred to the relevant instructions in the instructions for use.

• 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: 50881985
• Report Number: 3003923579-2026-00025
• Device Sequence Number: 13246628
• Product Code: HBL
• UDI-Device Identifier: 04250435506196
• UDI-Public: 04250435506196
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/24/2026
• Report Date (Section F): 09/24/2026

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?: Yes
• Date Returned to Manufacturer: 09/03/2026
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/27/2026
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/24/2026
• 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