NorthStar PC1-105534Recalls & reported problems
Seaspine Orthopedics Corporation · Poly. Screw, Favored Angle 5.5mm x 34mm · Class 2 · Implant
All models of NorthStar (24)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10889981197308), received between Jun 21, 2024 and Jun 21, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (2 reports).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture2
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 21, 2024Fracture; Fracture
ON 23 MAY 2024, A PATIENT UNDERWENT SPINAL SURGERY UTILIZING SEASPINE'S NORTHSTAR POSTERIOR CERVICAL FUSION SYSTEM. A FAVORED ANGLE SCREW BROKE JUST BELOW THE SCREW HEAD DURING INSERTION INTO THE LEFT SIDE OF THE T1 VERTEBRAE. A SECOND FAVORED ANGLE SCREW BROKE AT THE SAME POINT DURING INSERTION INTO THE RIGHT SIDE OF THE T1 VERTEBRAE. BOTH SCREW SHAFTS WERE REMOVED FROM THE PATIENT. THIS RESULTED IN A 20 TO 30-MINUTE SURGICAL DELAY. A STRAIGHT PROBE HAD BEEN USED TO CREATE BOTH SCREW PILOT HOLES. NO PATIENT INJURY WAS REPORTED. TWO SCREWS WERE RETURNED FOR EVALUATION; IT IS UNKNOWN WHICH SCREW IS ASSOCIATED WITH WHICH FRACTURE. THIS REPORT IS FOR LOT CR46588D.
Patient problems: Insufficient Information
MAUDE report 19584664 ↗MalfunctionJun 21, 2024Fracture; Fracture
ON (B)(6) 2024, A PATIENT UNDERWENT SPINAL SURGERY UTILIZING SEASPINE'S NORTHSTAR POSTERIOR CERVICAL FUSION SYSTEM. A POLYAXIAL, FAVORED ANGLE SCREW BROKE JUST BELOW THE SCREW HEAD DURING INSERTION INTO THE LEFT SIDE OF THE T1 VERTEBRAE. A SECOND POLYAXIAL, FAVORED ANGLE SCREW BROKE AT THE SAME POINT DURING INSERTION INTO THE RIGHT SIDE OF THE T1 VERTEBRAE. BOTH SCREW SHAFTS WERE REMOVED FROM THE PATIENT. THIS RESULTED IN A 20 TO 30-MINUTE SURGICAL DELAY. A STRAIGHT PROBE HAD BEEN USED TO CREATE BOTH SCREW PILOT HOLES. NO PATIENT INJURY WAS REPORTED. TWO SCREWS WERE RETURNED FOR EVALUATION; IT IS UNKNOWN WHICH SCREW IS ASSOCIATED WITH WHICH FRACTURE. THIS REPORT IS FOR LOT CR46075C.
Patient problems: Insufficient Information
MAUDE report 19584604 ↗
Other Posterior cervical screw system devices
- INFINITY™ Occipitocervical Upper Thoracic System 3604026Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation2 recalls1 report
- CONNECTOR 79-2002Orthofix 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
- 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
- OASYS 48551000Stryker Corporation · Orthosis, cervical pedicle screw spinal fixation45 reports
- SYMPHONY 1020-35-112Medos International Sàrl · Posterior cervical screw system6 deaths15 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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