ReLine 16171111Recalls & reported problems
Nuvasive, Inc. · RELINE Tulip, MOD · Class 2 · Implant
All models of ReLine (129)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00887517587497), received between Apr 30, 2018 and Mar 26, 2025 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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
- Detachment of Device or Device Component5
- Detachment Of Device Component1
- Malposition of Device1
- Migration or Expulsion of Device1
- Separation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Failure of Implant2
- Pain2
- Insufficient Information1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN 8-MONTH POST-OPERATIVE FOLLOW-UP IT WAS DISCOVERED THAT THE MODULAR TULIP HEAD HAD SEPARATED FROM THE TOP OF THE SCREW SHANK. TO DATE, NO REVISION PROCEDURE HAS BEEN SCHEDULED.
Patient problems: Insufficient Information
MAUDE report 21700698 ↗MalfunctionJun 21, 2024Separation Problem; Separation Problem
ON (B)(6) 2024 A PATIENT UNDERWENT A TRANSFORAMINAL LUMBAR INTERBODY FUSION FROM L4-S1. INTRA OPERATIVELY THE PATIENT EXPERIENCED 2 TULIP SEPARATIONS AT LEFT L4/L5 ((B)(6)) WHICH WERE ADDRESSED INTRA OPERATIVELY. THE SURGERY WAS COMPLETED WITHOUT ANY ADVERSE PATIENT CONSEQUENCES. ON (B)(6) 2024, WHILE STILL IN THE INTENSIVE CARE UNIT, IT WAS DISCOVERED DURING RADIOGRAPHIC REVIEW ANOTHER TULIP POPPED OFF AT S1 RT. NO REPORTED PATIENT SYMPTOMS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19580270 ↗MalfunctionApr 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ON (B)(6) 2024 A TRANSFORAMINAL LATERAL INTERBODY FUSION WAS CONDUCTED AT L4/S1. ON (B)(6) 2024 IT WAS DISCOVERED THE SCREW SHANK SEPARATED AT L4. NO PATIENT INJURIES WERE REPORTED. NO REVISION REPORTEDLY PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19089801 ↗MalfunctionMar 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
SCREW IMPLANTED ON (B)(6) 2022 AND FOUND ON FOLLOW UP NOT SEATED ON SHANK, SURGEON STATED MAY NOT HAVE FULLY SEATED TULIP ON SHANK. REPLACED (B)(6) 2023.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16651478 ↗MalfunctionFeb 24, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
ON (B)(6) 2020 A SPINAL PROCEDURE TOOK PLACE. ON (B)(6) 2021 A REVISION PROCEDURE TOOK PLACE DUE TO A TULIP REPORTEDLY DISCONNECTING FROM THE SHANK IN-SITU CAUSING MOBILITY OF THE SEGMENT AND THE SEGMENT RETURNED TO A GRADE 2 SPONDYLOLISTHESIS CAUSING THE PATIENT PAIN POST-OPERATIVELY. DURING THE REVISION PROCEDURE THE TULIP AND SHANK WERE REPLACED WITH A NEW SCREW OF A LARGER DIAMETER.
Patient problems: Pain
MAUDE report 11373022 ↗MalfunctionJun 28, 2018Detachment Of Device Component; Malposition of Device; Detachment Of Device Component; Malposition of Device
ON (B)(6) 2018 PATIENT UNDERWENT AN INTERBODY REPLACEMENT PROCEDURE WITH POSTERIOR FIXATION AT L2-L5 LEVELS WITH NO REPORTED ISSUES. POST-OPERATIVE PATIENT EXPERIENCED PAIN AND UNDERWENT A REVISION PROCEDURE ON (B)(6) 2018. DURING THE PROCEDURE A LOOSE TULIP WAS FOUND AT L2 LEVEL AND PEDICLE BREACH AT THE L1-L2 DISC SPACE. L2 SCREW AND LOCK SCREW WERE REPLACED.
Patient problems: Failure of Implant; Pain
MAUDE report 7649127 ↗MalfunctionApr 30, 2018Migration or Expulsion of Device; Detachment of Device or Device Component; Migration or Expulsion of Device; Detachment of Device or Device Component
ON (B)(6) 2018 A PATIENT UNDERWENT AN EXTREME LATERAL INTERBODY FUSION WITH LATERAL PLATE AND POSTERIOR FIXATION AT L4/L5 LEVELS. ON (B)(6) 2018 RADIOGRAPHS SHOWED A TULIP SEPARATION AT THE L4 RIGHT SIDE LEVEL AS WELL AS A CAGE MIGRATION. NO PATIENT HARM HAS BEEN REPORTED. NO REVISION PROCEDURE IS PLANNED AT THIS TIME.
Patient problems: Failure of Implant
MAUDE report 7473725 ↗
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- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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