ReLine 3900240Recalls & reported problems
Nuvasive, Inc. · RELINE C Lock Screw, Open · Class 2 · Implant
All models of ReLine (129)
Data updated Oct 16, 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 00195377068064), received between Apr 14, 2023 and Apr 14, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
DURING A SIX (6) WEEK POSTOPERATIVE FOLLOW-UP WITH A PATIENT THAT HAD UNDERGONE A CERVICAL FIXATION PROCEDURE, IT WAS FOUND THAT TWO (2) LOCK SCREWS HAD BACKED OUT OF THE PEDICLE SCREW TULIPS AT T1. ALL OTHER SCREWS IN THE CONSTRUCT APPEARED TO BE IN THE CORRECT POSITIONS. NO REVISION PROCEDURE IS SCHEDULED AT THIS TIME. MEDWATCH 2 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16742888 ↗MalfunctionApr 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
DURING A SIX (6) WEEK POSTOPERATIVE FOLLOW-UP WITH A PATIENT THAT HAD UNDERGONE A CERVICAL FIXATION PROCEDURE, IT WAS FOUND THAT TWO (2) LOCK SCREWS HAD BACKED OUT OF THE PEDICLE SCREW TULIPS AT T1. ALL OTHER SCREWS IN THE CONSTRUCT APPEARED TO BE IN THE CORRECT POSITIONS. NO REVISION PROCEDURE IS SCHEDULED AT THIS TIME. MEDWATCH 1 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16742878 ↗
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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