NorthStar PC1-104532Recalls & reported problems
Seaspine Orthopedics Corporation · Poly. Screw, Favored Angle 4.5mm x 32mm · 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 10889981197070), received between Nov 25, 2025 and Nov 25, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Positioning Problem” (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.
Reports received per month
Most reported problems
Device problems
- Positioning Problem1
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.
MalfunctionNov 25, 2025Positioning Problem; Positioning Problem
ON (B)(6) 2025 SEASPINE/ORTHOFIX BECAME AWARE THAT A SCREW DISSEMBLED INTRA-OPERATIVELY DURING A SURGERY UTILIZING THE NORTHSTAR OCT SPINAL SYSTEM. THE SURGEON WAS ADJUSTING THE HEIGHT OF THE FAVORED ANGLE SCREW (PC1-104532) WITH A FINAL DRIVER, WHEN THE SCREW DISASSEMBLED. THE SURGEON WAS MAKING HEIGHT ADJUSTMENTS TO THE SCREW WHEN THE WASHER DISLODGED. PER THE REPORTER, ALL THE PIECES WERE RETRIEVED. THIS LED TO A DELAY OF APPROXIMATELY 30 MINUTES; PROMPTING THIS REPORT. THE SURGERY WAS ABLE TO BE COMPLETED SUCCESSFULLY, AND NO PATIENT INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23646598 ↗
Other Posterior cervical screw system devices
- INFINITY™ Occipitocervical Upper Thoracic System 3604026Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation2 recalls1 report
- CONNECTOR 79-2003Orthofix US LLC · Posterior cervical screw system1 recall0 reports
- INFINITY™ Occipitocervical Upper Thoracic System 360PT4022Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation1 recall0 reports
- CONNECTOR 79-2002Orthofix US LLC · Posterior cervical screw system1 recall0 reports
- INFINITY™ Occipitocervical Upper Thoracic System 3604532Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation1 recall0 reports
- INFINITY™ Occipitocervical Upper Thoracic System 3604024Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation1 recall0 reports
- OASYS 48551000Stryker Corporation · Orthosis, cervical pedicle screw spinal fixation45 reports
- YUKON OCT Spinal System 7601-05030VB Spine LLC · Orthosis, cervical pedicle screw spinal fixation15 reports
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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