MAUDE Adverse Event Report: PRO MED INSTRUMENTS GMBH 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	05/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer has not yet sent in the product for investigation.We will perform a follow-up as soon as the product has arrived and the findings have been completed.
Event or Problem Description
A customer informed us that one of our products was involved in a surgery (ventriculoperitoneal shunt) in which the patient's head fell out of the clamp and the patient sustained superficial lacerations.
Additional Manufacturer Narrative
The product involved was not yet available for investigation at the time of the initial report.In this report, the results of the findings and all related cognitions have been supplemented in this report.It is not assumed that the deviating torque screw of the skull clamp did contribute to the incident described.In our experience, the pinning technique is decisive for the stability of the fixation of the patient's skull.It cannot be excluded that the pinning technique in this case was not optimal, as described in the instruction manual: "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." we recommend using our skull pins in combination with our skull clamps.Risks due to not permitted system combinations with third party components could not be excluded, as in this case.
Event or Problem Description
A customer informed us on (b)(6) that one of our products was involved in a surgery (ventriculoperitoneal shunt) in which the patient's head fell out of the clamp and the patient sustained superficial lacerations.

• Brand Name: DORO® SKULL CLAMP RADIOLUCENT
• 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: 17225129
• Report Number: 3003923584-2023-00018
• Device Sequence Number: 7206820
• Product Code: HBL
• UDI-Device Identifier: 04250435502181
• UDI-Public: 04250435502181
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2023

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2023
• Supplement Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2023
• 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