MAUDE Adverse Event Report: PRO MED INSTRUMENTS GMBH DORO® STERILE DISPOSABLE SKULL PINS; DORO® STERILE DISPOSABLE SKULL PIN STAINLESS STEEL, ADULT (36 PCS)

Model Number	3006-50
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	06/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device reportedly involved in the incident described has not yet been submitted for examination.Additional information on the other system components used in this case has been requested, as well as the return of the devices involved for examination.Any findings will be presented in a follow-up report, if applicable.
Event or Problem Description
Canadian authority informed us on june 18 that one of our products was involved in a case in which the patient sustained a laceration.
Additional Manufacturer Narrative
The distributor confirmed that the involved skull pins were discarded by the hospital and are therefore not available for analysis.Additional information on the other components of the headrest system used in this case, such as the skull clamp, are not available.The root cause of the problem can not be conclusively evaluated, as the involved device(s) are not available for analysis.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." the customer's attention is drawn to the pinning recommendation stated wihtin the product's ifu.The customer is furthermore advised of the importance of retaining/returning medical devices involved in such incidents resulting in patient injury or other unexpected risks, as well as identifying the other components of the headrest system used.The following contents were adapted within this follow-up reporting: b6, g3, g6, h2, h6 (b,c,d), h11.

• Brand Name: DORO® STERILE DISPOSABLE SKULL PINS
• Common Device Name: DORO® STERILE DISPOSABLE SKULL PIN STAINLESS STEEL, ADULT (36 PCS)
• 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: 22494026
• Report Number: 3003923584-2025-00017
• Device Sequence Number: 18189715
• Product Code: HBL
• UDI-Device Identifier: 04250435501115
• UDI-Public: 04250435501115
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K193438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2025

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: 3006-50
• Device Catalogue Number: 3006-50
• Device Lot Number: 855168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown