ReLine 16016550Recalls & reported problems
Nuvasive, Inc. · RELINE MAS Screw, 6.5x50mm 2C Polyaxial · Class 2 · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887517553591), received between Oct 25, 2017 and Apr 8, 2019 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Unintended Movement” (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.
Most reported problems
Device problems
- Unintended Movement2
- Migration or Expulsion of Device1
Patient problems
- Failure of Implant3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 8, 2019Unintended Movement; Unintended Movement
ON (B)(6) 2018, PATIENT UNDERWENT A POSTERIOR LUMBAR INTER-BODY FUSION PROCEDURE WITH POSTERIOR FIXATION AT L3/4 LEVELS WITHOUT ANY REPORTED EVENTS. AS PER REPORTER, ON (B)(6) 2019, A CAGE LOOSENING AND A SCREW BACK OUT WAS CONFIRMED. ON (B)(6) 2019, PATIENT UNDERWENT A REVISION PROCEDURE WHERE ALL IMPLANTS WERE REMOVED AND REPLACED AND CONSTRUCT WAS EXTENDED FROM L2/5.
Patient problems: Failure of Implant
MAUDE report 8494109 ↗MalfunctionFeb 27, 2019Migration or Expulsion of Device; Migration or Expulsion of Device
ON (B)(6) 2019, A PATIENT WITH VERTEBRAL BODY FRACTURE AT T12 UNDERWENT THE FIRST OF A TWO STAGE PROCEDURE REQUIRING A POSTERIOR SPINAL FUSION AT T9-L2 LEVELS SKIPPING SCREW FIXATION AT THE T12. POSTOPERATIVE IMAGE REVEALED SCREW BACK OUT AT L1 AND L2 LEVELS. ON (B)(6) 2019, DURING THE SECOND STAGE, A CORPECTOMY AT T12 A REVISION PROCEDURE WAS ALSO PERFORMED TO REPLACE THE TWO BACKED OUT SCREWS AT L1 AND L2 AND EXTENDING THE CONSTRUCT TO L3.
Patient problems: Failure of Implant
MAUDE report 8375895 ↗InjuryOct 25, 2017Unintended Movement; Unintended Movement
ON (B)(6) 2017, A PATIENT UNDERWENT A POSTERIOR LUMBAR INTERBODY FUSION PROCEDURE AT L4-5 LEVELS FOLLOWED BY POSTERIOR SPINAL FIXATION AT T8-L5 LEVELS. POST-OPERATIVE RADIOGRAPHS SHOWED THE L5 SCREW WAS NOT ANGLED CORRECTLY AND DEVIATED INTO THE SPINAL CANAL. ON (B)(6) 2017 A REVISION PROCEDURE WAS PERFORMED WHERE THE L5 SCREW WAS EXPLANTED AND RE-IMPLANTED IN THE CORRECT ANGLE.
Patient problems: Failure of Implant
MAUDE report 6976945 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.