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

Model Number	515400D
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/11/2021
Type of Reportable Event	Death
Event or Problem 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1836248-2021-00001
• Device Sequence Number: 4491932
• Product Code: LYT
• UDI-Device Identifier: 05690977308657
• UDI-Public: 05690977308657
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K040363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/01/2021

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
• Operator of Device: Health Professional
• Device Model Number: 515400D
• Device Catalogue Number: 515400D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 05/11/2021; 05/11/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 07/20/2021; 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Death
• Patient Sex: Unknown