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NorthStar PC1-714014Recalls & reported problems

Seaspine Orthopedics Corporation · OCC Screw, 4.0mm x 14 · 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 10889981259648), received between Mar 21, 2023 and Mar 21, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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

  • Fracture1

Patient problems

  • Foreign Body In Patient1
  • 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 21, 2023Fracture; Fracture

    A PATIENT UNDERWENT SPINAL SURGERY CONSISTING OF SEASPINE'S NORTHSTAR SYSTEM. SEASPINE WAS MADE AWARE ON (B)(6) 2023 THAT A (B)(4) OCC SCREW, 4.0MM X 14 FRACTURED IN-SITU. THE FRACTURED SCREW REMAINED IN THE PATIENT. THE INDEX SURGERY WAS ON (B)(6) 2023.

    Patient problems: Foreign Body In Patient; Insufficient Information

    MAUDE report 16583547 ↗

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.