ReLine 16016545Recalls & reported problems
Nuvasive, Inc. · RELINE MAS Screw, 6.5x45mm 2C Polyaxial · Class 2 · Implant
All models of ReLine (129)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887517553584), received between Oct 1, 2018 and Feb 14, 2024 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Migration1
Patient problems
- Failure of Implant2
- Vertebral Fracture1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryFeb 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2023 AN EXTREME LATERAL INTERBODY FUSION WAS PERFORMED AT L1/5. T10/S2 WAS FIXATED WITH POSTERIOR FIAXTION. POST-OPERATIVELY ON AN UNKNOWN DATE A VERTEBRAL COMPRESSION FRACTURE OCCURRED AT T10 AND PARALYSIS DEVELOPED. ON (B)(6) 2024 A REVISION SURGERY WAS CONDUCTED TO EXTEND THE FIXATION TO T7. THE SURGEON NOTED THERE WAS A CORRELATION BETWEEN THE VERTEBRAL FRACTURE AND PATIENT'S POOR BONE QUALITY.
Patient problems: Vertebral Fracture
MAUDE report 18707281 ↗MalfunctionJun 25, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
MalfunctionOct 1, 2018Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration
ON (B)(6) 2018, PATIENT WITH A FRACTURED L1 UNDERWENT A POSTERIOR LUMBAR INTERBODY FUSION AT L2/L3 LEVELS WITH POSTERIOR FIXATION FROM T10-L3. A LOOSE SCREW AT L3 AND A CAGE BACK OUT WAS IDENTIFIED POST-OPERATIVE. ON (B)(6) 2018 A REVISION PROCEDURE WAS PERFORMED TO REPLACE THE L3 LEVEL SCREW AND THE CAGE. CONSTRUCT WAS ALSO EXTENDED FROM T10 TO S2 AND A CROSS CONNECTOR WAS ADDED. NO PATIENT INJURY REPORTED.
Patient problems: Failure of Implant
MAUDE report 7924634 ↗
Other ORTHOSIS, SPINAL PEDICLE FIXATION devices
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- CREO 1134.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION112 reports
- CREO 1119.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION80 reports
- VIPER 186731745Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION43 reports
- CD HORIZON® Spinal System 1553201090Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION38 reports
- EXPEDIUM 179902000Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION37 reports
- CD HORIZON® Spinal System 7540220Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION36 reports
- EXPEDIUM VERSE 199721640Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION35 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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