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	06/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
German authorities (bfarm) informed us on july 9 that one of our products was involved in a case in which the treated patient sustained bilateral head injuries at the contact points of the skull clamp.
Additional Manufacturer Narrative
The clamp was returned following notification that it had been involved in an incident where the patient sustained bilateral head injuries at the contact points of the skull clamp caused by a slippage during patient positioning.Based on the findings of the investigation, no direct causal link can be established between the skull clamp that was sent and the incident described.The deviations identified (slight deviation in clamping force (~ 2%); signs of wear on the torque screw's thread and thread inserts of the skull clamp) presumably did not cause or contribute to the described incident.The maintenance interval for the torque screw has been exceeded; the deviations could not have remained undetected during the standard product inspection as part of the annual maintenance specified in the product ifu.From our experience, the pinning technique can contribute to slippage.In this context, we refer to 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.".

• 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: julia hundertmark ; boetzinger strasse 86; freiburg im breisgau, baden-wuerttemberg 79111 ; GM 79111
• MDR Report Key: 50081256
• Report Number: 3003923584-2026-00020
• Device Sequence Number: 13316751
• 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
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Risk Manager
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 07/30/2026

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: 07/20/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2026
• Initial Report FDA Received Date: 07/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2015
• 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