NorthStar PC1-524055Recalls & reported problems
Seaspine Orthopedics Corporation · Transition Ti Rod, 4.0mm to 5.5mm, 500mm · Class 2 · Implant
All models of NorthStar (24)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10889981199036), received between Dec 14, 2021 and Dec 14, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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
Device problems
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 14, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
OBSERVATION OF FILMS TAKEN POST-OPERATIVELY ON (B)(6) " 2921", SHOW ROD SLIPPAGE. THE FIRST SCREW IS IN THE BONE; HOWEVER, THE ROD IS NOT IN THE SET SCREW AS EXPECTED. THE ROD CAN BE SEEN BELOW THE LEVEL OF THE FIRST SCREW. THERE IS NO INDICATION OF THE SET CAPS FLOATING. THE SURGEON STATES THAT IT WAS A DIFFICULT CASE WITH MAJOR DEFORMITY IN THE PATIENT, AS WELL AS POOR BONE QUALITY. THE PATIENT DECLINES FURTHER ACTION. AS SUCH, THE SURGEON WILL MONITOR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12999075 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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