ReLine 12355300Recalls & reported problems
Nuvasive, Inc. · RELINE MAS Ti Rod, 5.5x300mm Straight · 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 00887517506764), received between Jun 2, 2017 and Nov 3, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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
- Fracture2
Patient problems
- Failure of Implant1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 3, 2021Fracture; Fracture
ON (B)(6) 2021 A PATIENT UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION PROCEDURE ON UNKNOWN LEVELS OF THE SPINE AND THE SURGERY WAS COMPLETED WITHOUT ISSUE. ON A UNKNOWN DATE NEAR THE END OF (B)(6) THE PATIENT WAS BENDING OVER AND FELT A POP. ON (B)(6) THE PATIENT FOLLOWED UP WITH THE SURGEON AND IT WAS DISCOVERED VIA RADIOGRAPH THAT A IMPLANTED ROD HAD FRACTURED. A REVISION OCCURRED ON (B)(6) 2021 WHERE THE FRACTURED ROD WAS REPLACED. DURING THE REVISION THE DOCTOR NOTED PSEUDO ARTHROSIS AT L4-5, L5-S1. THE PATIENT IS DOING WELL POST REVISION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12747778 ↗MalfunctionJun 2, 2017Fracture; Fracture
ON (B)(6) 2016 A PATIENT UNDERWENT A MULTI-LEVEL INTERBODY PLACEMENT PROCEDURE WITH POSTERIOR FIXATION FROM T9 TO S1 WITHOUT ISSUE. APPROXIMATELY ONE MONTH LATER DURING FOLLOW UP A ROD FRACTURE WAS OBSERVED ON RADIOGRAPHS. NO REVISION IS PLANNED AT THIS TIME. NO PATIENT INJURY HAS BEEN REPORTED.
Patient problems: Failure of Implant
MAUDE report 6608773 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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