MAUDE Adverse Event Report: PRO MED INSTRUMENTS GMBH MAYFIELD SCULL CLAMP; DORO HEAD FIXATION DEVICE

Device Problem Insufficient Information (3190)

Patient Problem Laceration(s) (1946)

Event Date 05/03/2017

Event Type  Injury  

Event Description

On (b)(6) 2017 the patient was taken to the operating room for a posterior fossa craniotomy and removal of a tumor.In the operating room prior to prone positioning the patient had three point pin placement in a doro securement device (the device).During final adjustments to the pins the patient's head moved resulting in a 3-4 cm superficial scalp laceration requiring sutures.

• Brand Name: MAYFIELD SCULL CLAMP
• Type of Device: DORO HEAD FIXATION DEVICE
• Manufacturer (Section D): PRO MED INSTRUMENTS GMBH; freiburg 79111 ; GM 79111
• MDR Report Key: 6721553
• MDR Text Key: 80465465
• Report Number: MW5071068
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/14/2017

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/14/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 16 YR
• Patient Weight: 47