NorthStarRecalls & reported problems across all models
Seaspine Orthopedics Corporation · 24 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one NorthStar model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 24 models of NorthStar by Seaspine Orthopedics Corporation in the FDA's device registry (GUDID). Together they are named in 15 adverse event reports in the FDA's MAUDE database, received between Dec 14, 2021 and Feb 17, 2026 — classified as 15 malfunctions.
The most frequently reported specific device problem is “Fracture” (6 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
NorthStar recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Nov 17, 2025Open, Classified
The NorthStar OCT Navigation Surgical Technique Guide (STG) incorrectly identified both Medtronic s Solera and Medtronic s Infinity system toolcards as compatible with the NorthStar OCT Navigation Instruments. However, the NorthStar OCT Navigation Instruments are compatible for use with Medtronic s Solera toolcards only.
Z-0937-2026 · Root cause: Labeling design · names 11 of these models · Recall details · FDA record ↗
Most reported NorthStar problems
Device problems
- Fracture6
- Detachment of Device or Device Component2
- Device Dislodged or Dislocated1
- Material Fragmentation1
- Material Integrity Problem1
- Material Separation1
- Off-Label Use1
- Patient Device Interaction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- Insufficient Information7
- Foreign Body In Patient1
NorthStar models
24 models, most reported first. Each model has its own page with its reports, recalls and device details.
- NorthStar PC2-400012Orthopedic stereotaxic instrument1 recall0 reports
- NorthStar PC2-400013Orthopedic stereotaxic instrument1 recall0 reports
- NorthStar PC2-400135Orthopedic stereotaxic instrument1 recall0 reports
- NorthStar PC2-400140Orthopedic stereotaxic instrument1 recall0 reports
- NorthStar PC2-400145Orthopedic stereotaxic instrument1 recall0 reports
- NorthStar PC2-400155Orthopedic stereotaxic instrument1 recall0 reports
- NorthStar PC2-400235Orthopedic stereotaxic instrument1 recall0 reports
- NorthStar PC2-400240Orthopedic stereotaxic instrument1 recall0 reports
- NorthStar PC2-400345Orthopedic stereotaxic instrument1 recall0 reports
- NorthStar PC2-400355Orthopedic stereotaxic instrument1 recall0 reports
- NorthStar PC2-400245Orthopedic stereotaxic instrument1 recall0 reports
- NorthStar PC1-105534Posterior cervical screw system2 reports
- NorthStar PC1-700003APPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- NorthStar PC1-003524Posterior cervical screw system1 report
- NorthStar PC1-004018Posterior cervical screw system1 report
- NorthStar PC1-004020Posterior cervical screw system1 report
- NorthStar PC1-104532Posterior cervical screw system1 report
- NorthStar PC1-105530APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- NorthStar PC1-400000APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- NorthStar PC1-524055APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- NorthStar PC1-524060Posterior cervical screw system1 report
- NorthStar PC2-200014Orthopedic manual surgical instrument1 report
- NorthStar PC1-714014APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- NorthStar PC1-700000Posterior cervical screw system1 report
Recent NorthStar adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionFeb 17, 2026Structural Problem
DURING A SURGERY THAT TOOK PLACE ON (B)(6) 2026, THE NORTHSTAR TORQUE LIMITING HANDLE BOUND DURING USE. THE DISTRIBUTOR REPRESENTATIVE REPORTED THAT THERE WAS NO BACKUP INSTRUMENT AVAILABLE, THEREFORE, THE SURGEON HAD TO PROCEED WITH MANUAL TIGHTENING AND COULD NOT CONFIRM WHETHER THE FINAL CONSTRUCT WAS TIGHTENED TO THE SPECIFIED TORQUE. ALTHOUGH NO PATIENT INJURY WAS REPORTED, THE INABILITY TO VERIFY THAT THE CONSTRUCT WAS TIGHTENED TO THE VALIDATED TORQUE SPECIFICATION MAY COMPROMISE CONSTRUCT STABILITY POST-OPERATIVELY. BASED ON THIS RISK AND THE POTENTIAL FOR PATIENT HARM, THE EVENT WAS DETERMINED TO BE REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24369358 ↗MalfunctionJan 22, 2026Off-Label Use
DURING A SURGERY THAT TOOK PLACE ON (B)(6) 2025, A PIECE OF THE NORTHSTAR OCCIPITAL PLATE BROKE OFF AND BECAME LODGED IN THE NORTHSTAR OCCIPITAL PLATE BENDING WRENCH. THE DISTRIBUTOR REP REPORTED THAT ALL OF THE FRACTURED PIECES WERE RETRIEVED, HOWEVER, THE OCCIPITAL PLATE WAS IMPLANTED WITHOUT A PORTION OF THE PLATE. AS THE SURGERY WAS COMPLETED WITHOUT A PORTION OF THE PLATE, ORTHOFIX/SEASPINE CANNOT GUARANTEE THE STABILITY OF THE CONSTRUCT POST-OPERATIVELY; THEREFORE, BASED ON THIS RISK CHARACTERIZATION, THE EVENT WAS DETERMINED TO BE REPORTABLE. NO PATIENT INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24158108 ↗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 ↗MalfunctionAug 8, 2025Separation Problem; Separation Problem
A PATIENT UNDERWENT POSTERIOR CERVICAL FUSION SPINE SURGERY ON (B)(6) 2025 UTILIZING SEASPINE/ORTHOFIX'S NORTHSTAR OCCIPITAL SYSTEM. AT A ROUTINE FOLLOW-UP VISIT ON (B)(6) 2025, RADIOGRAPHS DEMONSTRATED CONSTRUCT SEPARATION AT THE OCCIPITAL PLATE. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 22754744 ↗MalfunctionOct 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ON (B)(6) 2024, A PATIENT UNDERWENT SPINAL SURGERY UTILIZING SEASPINE'S NORTHSTAR OCT POSTERIOR CERVICAL FUSION SYSTEM. DURING A FOLLOW-UP ON (B)(6) 2024, A ROD FRACTURE WAS OBSERVED. APPROXIMATELY A WEEK LATER THE OCCIPITAL PLATE TULIP WAS OBSERVED TO HAVE DISASSOCIATED WITH THE PLATE. BOTH DEVICES REMAIN IMPLANTED. IT IS UNKNOWN IF A REVISION SURGERY IS PLANNED. NO PATIENT INJURY WAS REPORTED. THIS REPORT IS FOR THE PC1-700003 EL CAPITAN OCC PLATE, SMALL.
Patient problems: Insufficient Information
MAUDE report 20534195 ↗MalfunctionOct 24, 2024Fracture; Fracture
ON (B)(6) 2024, A PATIENT UNDERWENT SPINAL SURGERY UTILIZING SEASPINE'S NORTHSTAR OCT POSTERIOR CERVICAL FUSION SYSTEM. DURING A FOLLOW-UP ON (B)(6) 2024, A ROD FRACTURE WAS OBSERVED. APPROXIMATELY A WEEK LATER THE OCCIPITAL PLATE TULIP WAS OBSERVED TO HAVE DISASSOCIATED WITH THE PLATE. BOTH DEVICES REMAIN IMPLANTED. IT IS UNKNOWN IF A REVISION SURGERY IS PLANNED. NO PATIENT INJURY WAS REPORTED. THIS REPORT IS FOR THE PC1-524060 TRANSITION TI ROD, 4.0MM TO 6.0MM, 500MM.
Patient problems: Insufficient Information
MAUDE report 20529992 ↗MalfunctionSep 6, 2024Fracture; Fracture
ON (B)(6) 2024, A PATIENT UNDERWENT SPINAL SURGERY UTILIZING SEASPINE'S NORTHSTAR OCT POSTERIOR CERVICAL FUSION SYSTEM. WHEN TRYING TO REMOVE A SCREW, IT BROKE AT THE NECK. THE SCREW SHANK WAS LEFT IMPLANTED. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20164162 ↗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 ↗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 ↗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 ↗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 ↗MalfunctionDec 21, 2021Material Separation; Material Separation
A PATIENT UNDERWENT SPINAL SURGERY ON (B)(6) 2021 CONSISTING OF SEASPINE'S NORTHSTAR OCT SPINAL SYSTEM. A SCREW DISASSEMBLED IN-SITU WHILE THE SURGEON WAS CORRECTING THE TRAJECTORY. THE SCREW AND MATING TULIP WERE RECOVERED; HOWEVER, THE TULIP WASHER WAS LEFT INSIDE THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13051246 ↗MalfunctionDec 20, 2021Material Fragmentation; Material Integrity Problem; Material Fragmentation; Material Integrity Problem
A PATIENT UNDERWENT C4-T1 SPINAL SURGERY (B)(6) 2021 AS THE RESULT OF A MOTOR VEHICLE ACCIDENT. THE PATIENT REPORTEDLY HAD AN UNSTABLE CERVICAL SPINE WITH NEUROLOGIC DEFICIT. UPON INSERTION OF THE FINAL SCREW (RIGHT C4), THE SCREW FRACTURED. THE SURGEON ATTEMPTED TO REMOVE THE SCREW WITH A SCREW EXTRACTOR; HOWEVER, THE SCREW FRACTURED AGAIN AND WAS LEFT INSIDE THE LATERAL MASS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13047884 ↗MalfunctionDec 14, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
OBSERVATION OF FILMS TAKEN POST-OPERATIVELY ON (B)(6) " 2921", SHOW ROD SLIPPAGE. THE FIRST SCREW IS IN THE BONE; HOWEVER, THE ROD IS NOT IN THE SET SCREW AS EXPECTED. THE ROD CAN BE SEEN BELOW THE LEVEL OF THE FIRST SCREW. THERE IS NO INDICATION OF THE SET CAPS FLOATING. THE SURGEON STATES THAT IT WAS A DIFFICULT CASE WITH MAJOR DEFORMITY IN THE PATIENT, AS WELL AS POOR BONE QUALITY. THE PATIENT DECLINES FURTHER ACTION. AS SUCH, THE SURGEON WILL MONITOR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12999075 ↗
Other Seaspine Orthopedics Corporation products
- Mariner15 models · 147 reports · 1 recall
- Daytona Small Stature3 models · 14 reports · 2 recalls
- Fathom3 models · 2 reports · 2 recalls
- Meridian8 models · 8 reports · 1 recall
- Mariner Deformity3 models · 2 reports · 1 recall
- Virata25 models · 0 reports · 1 recall
- Reef TA2 models · 0 reports · 1 recall
- Mariner RDX6 models · 0 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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