Halo Systems 515400DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05690977308657), received between Apr 15, 2020 and Jun 9, 2021 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Malposition of Device” (1 report).

7 other recalls cover devices cleared under the same FDA submission (K051918); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathJun 9, 2021Use of Device Problem; Unintended Movement

  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.

  Patient problems: Unspecified Infection

  MAUDE report 11967400 ↗
• InjuryApr 15, 2020Malposition of Device

  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.

  Patient problems: Brain Injury; Seizures; Swelling

  MAUDE report 9961409 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051918. One submission often covers many models, so check the product and lot details in each record.

• Z-0999-2019 · Jun 21, 2018 · Terminated
  Ossur OB Resolve, Sterile, Part/ Description: 505300D/ OB RESOLVE STERILE RING SML; 505400D/ OB RESOLVE RING KIT STD; 505500D/ OB RESOLVE RING KIT LRG; 515300D/ OB RESOLVE RING K
• Z-1001-2019 · Jun 21, 2018 · Terminated
  Ossur, Sterile, Part/ Description: 505300T/ CB RING KIT TI SM; 505300V2/ OB V2 RING KIT TI SM; 505400T/ CB RING KIT TI STD; 505400V2/ OB V2 RING KIT TI STD; 505500T/ CB RING KIT
• Z-1000-2019 · Jun 21, 2018 · Terminated
  Ossur CB Resolve, Sterile, Part/ Description: 505300C/ CB RESOLVE STERILE UNIT SML; 505400C/ CB RESOLVE STERILE UNIT STD; 505500C/ CB Resolve Sterile Unit LRG; 515300C/ CB RESOLV
• Z-1002-2019 · Jun 21, 2018 · Terminated
  Ossur, J Tong, Sterile, Part/ Description: JT-115/ J TONG MED/LGE-No App; JT-200/ J TONG ASSEMBLY SML/MED; JT-210/ J TONG ONLY SML/MED; JT-400/ J TONG COMPONENT TRAY
• Z-1507-2009 · Nov 9, 2008 · Terminated
  ReSolve Halo - Open Back Halo Ring, Model Number: 505300D The ReSolve Halo Ring is a fixation device used to immobilize a patient with a cervical spine injury.
• Z-1509-2009 · Nov 9, 2008 · Terminated
  ReSolve Halo - Open Back Halo Ring, Model Number: 510400D The ReSolve Halo Ring is a fixation device used to immobilize a patient with a cervical spine injury.
• Z-1508-2009 · Nov 9, 2008 · Terminated
  ReSolve Halo - Open Back Halo Ring, Model Number: 505400D The ReSolve Halo Ring is a fixation device used to immobilize a patient with a cervical spine injury.