MAUDE Adverse Event Report: BLACK FOREST MEDICAL GMBH DORO® SKULL CLAMP; DORO® SKULL CLAMP RADIOLUCENT

Model Number	3034-00
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Laceration(s) (1946)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
None of the defects found in the skull clamp returned for examination could be linked to the described slippage as contributing or causal factors.The worn threads on the starburst and the material alteration on the rocker arm, which slightly narrowed the skull pin interfaces (drill holes), are attributable to (material-related) wear and tear over many years of use without maintenance.The crack on the quick rail of the fixed arm implies external force, which, however, did not cause any further damage/deviations that could be identified on the device.The maintenance cycle of one year specified in the ifu was not adhered to for the device in question.The maintenance cycle has been exceeded by more than 11 years.The defects identified here would not have remained undetected/unrepaired during the annual routine inspection and maintenance.The reporting customer is made aware of this circumstance in the context of this complaint correspondence.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
Customer informed us on february 19 that one of our products was involved in a case in which a laceration occurred.

• Brand Name: DORO® SKULL CLAMP
• Common Device Name: DORO® SKULL CLAMP RADIOLUCENT
• 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: nicholas preissler ; boetzinger strasse 86; freiburg im breisgau, baden-wuerttemberg 79111 ; GM 79111
• MDR Report Key: 24399072
• Report Number: 3003923584-2026-00006
• Device Sequence Number: 15528761
• Product Code: HBL
• UDI-Device Identifier: 04250435502181
• UDI-Public: 04250435502181
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K063494
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Replace,Repair
• Type of Report: Initial
• Report Date (Section B): 02/20/2026

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: 3034-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2013
• 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