MAUDE Adverse Event Report: PRO MED INSTRUMENTS GMBH DORO® SKULL CLAMP RADIOLUCENT

Model Number 3034-00

Device Problem Device Slipped (1584)

Patient Problem Laceration(s) (1946)

Event Date 01/11/2024

Event Type  Injury  

Manufacturer Narrative

The rough-functioning locking wheel of the skull clamp's open-lock mechanism cannot have contributed to the incident described by the customer.The slight crack on the quick-rail of the skull clamp is a typical sign of improper handling (e.G.Dropping the product), although it cannot have contributed to the incident described.All other features of the product sent in comply with the specification and do not exhibit any defects in terms of functionality and safety.As it is not assumed that the detected deviation has contributed to the described incident (patient slipped while pinned), no causal link can be established between the slippage and the skull clamp sent in.In our experience, the pinning technique when clamping the patient head is decisive in relation to the prevention of slippages.Our recommendations in regards to the pinning technique is described in the product's 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.".

Event Description

Customer informed us on march 11 that one of our products was involved in a case (posterior cervical) in which the treated patient sustained a laceration.

• Brand Name: DORO® SKULL CLAMP RADIOLUCENT
• Type of Device: 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: 18967680
• MDR Text Key: 338472144
• Report Number: 3003923584-2024-00009
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 04250435502181
• UDI-Public: 04250435502181
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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: 03/11/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other