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NorthStar PC1-400000Recalls & reported problems

Seaspine Orthopedics Corporation · NorthStar OCT Set Screw · Class 2

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 10889981198213), received between Mar 25, 2022 and Mar 25, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Device Dislodged or Dislocated1
  • Patient Device Interaction Problem1

Patient problems

  • Insufficient Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 25, 2022Device Dislodged or Dislocated; Patient Device Interaction Problem; Device Dislodged or Dislocated; Patient Device Interaction Problem

    THE CUSTOMER REPORTED A ROD SLIPPED OUT FROM UNDERNEATH A C2 PEDICLE SCREW WHEN A PATIENT FELL. XRAYS TAKEN SHOWED THAT THE SET SCREW WASN'T ALL THE WAY DOWN AND APPEARED CROSS THREADED. REVISION SURGERY WAS PERFORMED ON (B)(6) 2022. THE INITIAL SURGERY WAS ON (B)(6) 2022.

    Patient problems: Insufficient Information

    MAUDE report 13904659 ↗

Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices

All APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.