ReLine 15355500Recalls & reported problems
Nuvasive, Inc. · RELINE-O Ti Rod, 5.5x500mm Straight · Class 2 · Implant
All models of ReLine (129)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887517510143), received between Nov 13, 2017 and Feb 26, 2026 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break2
- Adverse Event Without Identified Device or Use Problem1
- Crack1
Patient problems
- Failure of Implant2
- Back pain1
- Damage to Ligament(s)1
- Numbness1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryFeb 26, 2026Crack
IT WAS REPORTED THAT A REVISION SURGERY OCCURRED ON (B)(6) 2025 DUE TO IMAGING SHOWING THAT THERE WAS HARDWARE FAILURE OF THE LEFT CONNECTOR ROD NEAR L5.
Patient problems: Back pain
MAUDE report 24454381 ↗InjuryJul 2, 2019Break; Break
ON AN UNKNOWN DATE IN 2018, PATIENT HEARD A SOUND OF BREAKING AND THEN BEGAN TO EXPERIENCE NUMBNESS AT THE BREECH/HIP AND INFERIOR LIMB. PATIENT WENT TO THE HOSPITAL, WHERE A ROD FRACTURE WAS CONFIRMED. NO REVISION PROCEDURE WAS PERFORMED AS THE PATIENT DID NOT DESIRE IT. ON (B)(6) 2019, PATIENT UNDERWENT A REVISION PROCEDURE AND THE RODS WERE EXCHANGED AND AN ADDITIONAL THIRD ROD WAS PLACED. THE PATIENT IS REPORTED TO BE DOING WELL.
Patient problems: Failure of Implant; Numbness
MAUDE report 8755347 ↗MalfunctionJan 30, 2018Break; Break
ON (B)(6) 2017, A PATIENT UNDERWENT POSTERIOR SPINAL FUSION AT T4-ILIAC LEVELS. ON (B)(6) 2018, A FRACTURE OF ONE OF THE RODS WAS DETECTED AT L5-S1 LEVEL. A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2018, WHERE BOTH RODS AT L5-S1 LEVEL WERE CUT AND SCREWS AT S1-ILIAC LEVELS WERE REMOVED. PATIENT WAS REPORTED TO BE DOING WELL POST REVISION PROCEDURE.
Patient problems: Failure of Implant
MAUDE report 7229205 ↗InjuryNov 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2017, A PATIENT UNDERWENT AN EXTREME LATERAL INTERBODY FUSION PROCEDURE AT L2-L5 LEVELS AND A POSTERIOR FUSION PROCEDURE AT T9-S2AI LEVELS. DURING IN-SITU ROD BENDING, THE ANTERIOR LONGITUDINAL LIGAMENT WAS RUPTURED AT L2/3 LEVEL. REPORTEDLY, ON (B)(6) 2017, PATIENT UNDERWENT A REVISION PROCEDURE TO PLACE A MESH CAGE AND ARROW GRAFT IN AN EFFORT TO PREVENT THE XLIF CAGE FROM BACKING OUT. NO PATIENT INJURY WAS REPORTED.
Patient problems: Damage to Ligament(s)
MAUDE report 7025702 ↗
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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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