MAUDE Adverse Event Report: BLACK FOREST MEDICAL GMBH DORO® SKULL CLAMP; HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)

Model Number	1001.001
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	07/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon placed the clamp on the patient.The pins slipped causing a laceration.The surgeon placed staples in the skin.Rn took that mayfield out of service, and brought a different one in the room.

• Brand Name: DORO® SKULL CLAMP
• Common Device Name: HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)
• Manufacturer (Section D): BLACK FOREST MEDICAL GMBH; 4529 se 16th pl ste 101; cape coral FL 33904
• MDR Report Key: 24245671
• Report Number: 24245671
• Device Sequence Number: 8233567
• Product Code: HBL
• UDI-Device Identifier: 04250435506196
• UDI-Public: (01)04250435506196
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/20/2026
• Report Date (Section F): 01/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1001.001
• Device Catalogue Number: 1001.001.101; 1001.001
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 02/03/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2026
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/20/2026