ReLine 16014540Recalls & reported problems
Nuvasive, Inc. · RELINE MAS Screw, 4.5x40mm 2C Polyaxial · Class 2 · Implant
All models of ReLine (129)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517552853), received between Oct 16, 2018 and Nov 16, 2018 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Unintended Movement” (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
- Appropriate Device Problem Term/Code Not Available1
- Unintended Movement1
Patient problems
- Paralysis1
- Post Operative Wound Infection1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 16, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
POST REVISION SURGERY, PATIENT WAS REPORTED TO HAVE AN INFECTION. AS PER REPORTER PATIENT WAS PROVIDED ANTIBIOTICS AND UNDERWENT A SALINE WASHOUT.
Patient problems: Post Operative Wound Infection; Unspecified Infection
MAUDE report 8081726 ↗MalfunctionOct 16, 2018Unintended Movement; Unintended Movement
ON (B)(6) 2018, PATIENT UNDERWENT SPINAL FUSION PROCEDURE AT T9-S2 LEVELS AND SPINAL DECOMPRESSION AT T5/6 USING MULTIPLE PRODUCTS. POST-OPERATIVE PATIENT WAS EXPERIENCING NO LEG MOVEMENT. A DIAGNOSTIC IMAGING, CT AND MRI, WERE PERFORMED AND REVEALED A SIGNAL CHANGE AT LEVELS T6/7. A REVISION PROCEDURE TO EXTEND THE CONSTRUCT IS PLANNED.
Patient problems: Paralysis
MAUDE report 7970247 ↗
Other ORTHOSIS, SPINAL PEDICLE FIXATION devices
- NA 04.614.508Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION277 reports
- 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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