ReLine 3904012Recalls & reported problems
Nuvasive, Inc. · RELINE C Screw, 4.0x12mm MA · Class 2 · Implant
All models of ReLine (129)
Data updated Oct 18, 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 00195377068750), received between Aug 10, 2023 and Aug 10, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 18, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
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.
MalfunctionAug 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ON (B)(6) 2023 A PATIENT UNDERWENT A POSTERIOR CERVICAL FUSION PROCEDURE ON UNCONFIRMED LEVELS OF THE SPINE AND THE SURGERY WAS COMPLETED WITHOUT ISSUE. ON THE FOLLOWING DAY OF (B)(6) 2023 RADIOGRAPHS DISCOVERED A SCREW TULIP HEAD ON THE LEFT SIDE OF THE CONSTRUCT HAD DISASSOCIATED. THE PATIENT EXPERIENCED NO ADVERSE CONSEQUENCES AS A RESULT OF THE DEVICE ISSUE. A REVISION OCCURRED ON (B)(6) 2023 WHERE THE DAMAGED SCREW, SET SCREW AND LEFT SIDE ROD WERE REPLACED. THE REVISION WAS COMPLETED WITHOUT ISSUE AND THE PATIENT HAS BEEN DISCHARGED AND IS DOING WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17503106 ↗
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- XIA 3 48230000Stryker Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL193 reports
- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
- NA 04.614.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL80 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
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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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