MAUDE Adverse Event Report: OSSUR AMERICAS RESOLVE HALO; TRACTION SYSTEM

Model Number 515400D

Device Problem Malposition of Device (2616)

Patient Problems Seizures (2063); Swelling (2091); Brain Injury (2219)

Event Date 12/30/2019

Event Type  Injury  

Manufacturer Narrative

Based on information known it is likely no failure or malfunction occurred with the device.The event likely occurred to pin penetration, which may have been due to improper application/maintenance of the pin tightness or may have been due to a fall/impact incident that was not related to a product malfunction.

Event Description

The patient had a halo vest fitted, this was readjusted to improve alignment a few days later.The patient was subsequently readmitted with a seizure.Imaging confirmed the posterior halo pins had breached the skull bilaterally and there was minor brain swelling.The patient was admitted to hospital, the halo vest was removed, and the patient treated with anticonvulsants and antibiotics.

• Brand Name: RESOLVE HALO
• Type of Device: TRACTION SYSTEM
• Manufacturer (Section D): OSSUR AMERICAS; 910 burstein dr.; albion, mi
• Manufacturer Contact: katla axelsdottir ; grjothals 1-5; reykjavik 110 ; IC 110
• MDR Report Key: 9961409
• MDR Text Key: 187685675
• Report Number: 0001836248-2020-00002
• Device Sequence Number: 1
• Product Code: HAX
• UDI-Device Identifier: 05690977308657
• UDI-Public: 05690977308657
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K051918
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 515400D
• Device Catalogue Number: 515400D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization