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

Model Number 515400D

Device Problems Use of Device Problem (1670); Unintended Movement (3026)

Patient Problem Unspecified Infection (1930)

Event Date 05/11/2021

Event Type  Death  

Event Description

A patient fitted with halo had problems with the pin sites over the duration of the use and the pins had to be replaced due to skull breaches.The device was removed but after 10 days the patient was admitted to the intensive care unit at his local hospital with a potential cns infection.It has not been confirmed that the pin site breach contributed to the event.

Event Description

A patient fitted with halo had problems with a pin site over the duration of the use and the pin had to be replaced due to skull breach.It has not been confirmed that the pin site breach contributed to the event since there were no evidence of infection.The device was removed after 12 week use but 10 days after removing the device the patient was admitted to the intensive care unit at his local hospital with a potential cns infection.The patient passed away on june 21st.

Event Description

A patient fitted with halo had problems with a pin site over the duration of the use and the pin had to be replaced due to skull breach.It has not been confirmed that the pin site breach contributed to the event since there were no evidence of infection.The device was removed after 12 week use but 10 days after removing the device the patient was admitted to the intensive care unit at his local hospital with a potential cns infection.The patient passed away on june 21st.

Manufacturer Narrative

The patient was placed in a halo due to fall causing a fracture on the c2.At 4 weeks pin penetration occurred, where the pin was removed and re-sited.At 12 weeks the halo was removed, and 10 days later the patient was admitted to the icu.Cns infection was suspected, but not confirmed.Within 2 weeks the patient passed away.The device was not returned for analysis, so product failure or malfunction could not confirmed.There is insufficient information to determine the root cause and whether the halo contributed to the patient being admitted to the icu.The cause of death is unknown and the autopsy report has not been provided.The likelihood of this type of failure leading to a hazardous event resulting in a serious or catastrophic injury is considered remote.We will continue to monitor this issue.

• Brand Name: RESOLVE HALO
• Type of Device: TRACTION DEVICE
• Manufacturer (Section D): OSSUR AMERICAS; 910 burstein dr.; albion MO
• Manufacturer Contact: katla axelsdottir ; grjothals 1-5; reykjavik, 110 ; IC 110
• MDR Report Key: 11967400
• MDR Text Key: 255336041
• Report Number: 1836248-2021-00001
• Device Sequence Number: 1
• Product Code: LYT
• UDI-Device Identifier: 05690977308657
• UDI-Public: 05690977308657
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K040363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 515400D
• Device Catalogue Number: 515400D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2021
• 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; Death