ReLine 16019590Recalls & reported problems
Nuvasive, Inc. · RELINE MAS Screw, 9.5x90mm 2C Poly Iliac · Class 2 · Implant
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887517554758), received between Jul 1, 2020 and Apr 23, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Fracture1
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Pain2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ON (B)(6) 2023 A PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE AT T2 TO PELVIS. ON (B)(6) 2024 RADIOGRAPHS IDENTIFIED 2 TULIPS SEPARATED FROM THE SHANKS, SURGEON PREROGATIVE WAS TO CONTINUE TO MONITOR THE PATIENT NO REVISION PLANNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21894221 ↗MalfunctionApr 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ON (B)(6) 2023 A PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE AT T2 TO PELVIS. ON (B)(6) 2024 RADIOGRAPHS IDENTIFIED 2 TULIPS SEPARATED FROM THE SHANKS, SURGEON PREROGATIVE WAS TO CONTINUE TO MONITOR THE PATIENT NO REVISION PLANNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21893446 ↗MalfunctionSep 25, 2020Fracture; Fracture
ON A UNKNOWN DATE IN (B)(6) 2020 PATIENT UNDERWENT A POSTERIOR LUMBAR INTERBODY FUSION PROCEDURE FROM T4-ASI LEVELS. THE PATIENT WAS EXPERIENCING PAIN POST PROCEDURE, AND AN X RAY WAS TAKEN ON (B)(6) 2020, WHERE IT WAS DISCOVERED THAT BOTH SCREWS AT S2AI HAD FRACTURED. THE PATIENT INITIALLY EXPERIENCED A PAIN, HOWEVER IS NOW ASYMPTOMATIC. AS PER REPORTER, THERE ARE NO PLANS FOR A REVISION PROCEDURE AT THIS TIME.
Patient problems: Pain
MAUDE report 10587205 ↗MalfunctionJul 1, 2020Migration; Migration
IN (B)(6) 2019, PATIENT UNDERWENT A SPINAL PROCEDURE ON T8/S2AI LEVELS WITH RELINE PRODUCT WITH NO REPORTED EVENTS. ON (B)(6) 2020 X-RAY FILMS WERE TAKEN AS PATIENT WAS EXPERIENCING PAIN, IT WAS IDENTIFIED THAT SET SCREWS OF S2AI HAD COME OFF. ON (B)(6) 2020 A REVISION PROCEDURE WAS PERFORMED.
Patient problems: Pain
MAUDE report 10222306 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.