MAUDE Adverse Event Report: PRO MED INSTRUMENTS 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)
Date of Event	05/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is not assumed that the pin force deviation on the torque screw of the returned skull clamp (<20 % at the force level reportedly applied during the procedure) was the cause of the slippage described.However, a contribution of this deviation to the described incident cannot be ruled out in general.It is suspected that cleaning parameters deviating from the specifications could have caused the deviation in the torque screw's pin force.The customer informed us that the positioning of the patient was changed during the surgery.Re-positioning the patient after fixation increases the risk of slippage due to higher forces acting on the headrest system and the patient's skull.It can not be excluded that this re-positioning also contributed to the reported incident.It has been reported that skull pins and a base unit from another manufacturer were used in combination with the skull clamp that was sent in.We recommend using our skull pins and base unit in combination with our skull clamps.Risks due to not permitted third party system combinations, specifically with skull pins from a third party manufacturer can not be excluded, as in this case.Furthermore, the condition of the third-party components used cannot be assessed (not available for inspection).It can therefore be ruled out that the use of system components from a third party manufacturer caused or contributed the described incident.In this context, we refer to our ifu instructions regarding the pinning technique for clamping the skull, which can often cause slippage and/or loss of clamping force: "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 our sales manager on may 16 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® SKULL CLAMP RADIOLUCENT
• Manufacturer (Section D): PRO MED INSTRUMENTS GMBH; boetzinger str. 86; freiburg, baden-wuerttemberg 79111 ; GM 79111
• Manufacturer (Section G): PRO MED INSTRUMENTS GMBH; boetzinger str. 86; freiburg, baden-wuerttemberg 79111 ; GM 79111
• Manufacturer Contact: nicholas preissler ; boetzinger str. 86; freiburg, baden-wuerttemberg 79111 ; GM 79111
• MDR Report Key: 22493407
• Report Number: 3003923584-2025-00016
• Device Sequence Number: 11799567
• Product Code: HBL
• UDI-Device Identifier: 04250435502181
• UDI-Public: 04250435502181
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair,Inspection
• Type of Report: Initial
• Report Date (Section B): 05/16/2025

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: 3034-00
• Device Catalogue Number: 3034-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2015
• 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