MAUDE Adverse Event Report: BRAINLAB AG STERILE RADIOLUCENT SKULL PINS; NEUROSURG. HEAD HOLDER (SKULL CLAMP)

Model Number 18911

Device Problem Insufficient Information (3190)

Patient Problems Abrasion (1689); Injury (2348)

Event Date 12/16/2014

Event Type  Injury  

Event Description

For a cranial surgery (tumor resection) it was planned to fixate the pt's head in a headclamp (3rd party device) equipped with the brainlab sterile radiolucent skull pins.The surgeon positioned the headclamp parallel to the floor and fixated the pts head with the brainlab pins.During the preparation of the actual surgery/incision the pt's head slipped out of the fixation on a side, causing an approximately 5 cm long skin cut at the pt's head.According to the hospital there was no other negative clinical effect for this pt due to this issue.The skin cut was sutured and there are no complications expected for this injury.The surgery could be continued with using pins from another manufacturer.

Manufacturer Narrative

A risk to the pt's health could not be excluded for these specific circumstances, since a failure of head fixation during a cranial surgery has occurred, with the brainlab device involved.A comprehensive investigation by brainlab regarding this specific event is currently ongoing and final conclusions are pending.Brainlab plans to issue a follow-up report to the fda upon completion of investigation.

Manufacturer Narrative

According to the results of brainlab investigation and the information provided by the hospital, it can be concluded that the root cause for the fact that the patient's head slipped out of the fixation is an error in the usage of the device.The surgeon did not follow the according brainlab instructions, specifying that the head holder device must be positioned along the centerline of the patient's head.There is no indication of an error or malfunction of the brainlab device.Corresponding brainlab measures to reduce this already anticipated risk to be as low as reasonably practicable are in place.Brainlab intends to offer additional training to users at this hospital.

• Brand Name: STERILE RADIOLUCENT SKULL PINS
• Type of Device: NEUROSURG. HEAD HOLDER (SKULL CLAMP)
• Manufacturer (Section D): BRAINLAB AG; kapellenstrasse 12; feldkirchen 8562 2; GM 85622
• Manufacturer Contact: julia mehltretter ; kapellenstrasse 12; feldkirchen 85622 ; GM 85622 ; 99915680
• MDR Report Key: 4495489
• MDR Text Key: 5504161
• Report Number: 8043933-2015-00001
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K122225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/16/2014

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
• Device Operator: Health Professional
• Device Model Number: 18911
• Device Catalogue Number: 18911
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2014
• Initial Date FDA Received: 01/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other