NorthStar PC1-105530Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10889981197285), received between Aug 4, 2023 and Aug 4, 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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2023Fracture; Fracture

  ON 13 JUL 2023 SEASPINE BECAME AWARE THAT A PC1-105530 POLY. SCREW, FAVORED ANGLE 5.5MM X 30MM FRACTURED INTRA-OPERATIVELY AND A PORTION OF THE SCREW REMAINED IN THE PATIENT. THE INDEX SURGERY TOOK PLACE ON (B)(6) 2023. ACCORDING TO THE REPORTER, THE SURGEON FREEHAND POWER-DRILLED WITH A 4.5MM DRILL AT T1. THIS WAS FOLLOWED WITH A 4.5MM TAP. THE BONE WAS NOTED TO BE SCLEROTIC AND NOT HARD. THE SURGEON THEN DROVE THE 5.5X30MM SCREW WITH A POLY DRIVER (THREADED) ABOUT ¾ OF THE WAY. THE SCREW FRACTURED AT THE NECK WHEN THE SCREW WAS APPROXIMATELY 4MM PROUD. THE REP NOTED THAT THE SURGEON WAS NOT TOO FORCEFUL. THE SURGEON CLEANED UP THE PROUD SCREW SHANK AND LEFT REMAINING PORTION IN PATIENT. CONSTRUCT ENDED AT T2. NO RADIOGRAPHS WERE PROVIDED. NO PATIENT INJURY WAS REPORTED AND NO FURTHER INFORMATION ON PATIENT CONDITION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17465453 ↗