ReLine 13116540Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00887517582492), received between Aug 24, 2017 and Jan 13, 2021 — classified as 5 malfunctions.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2019 A PATIENT UNDERWENT A POSTERIOR LUMBAR INTERBODY FUSION WITH A COMPETITOR'S CAGE AND NUVASIVE PRODUCTS AT L4/5. ON (B)(6) 2020 A REVISION SURGERY WAS PERFORMED DUE TO THE COMPETITOR'S CAGE BACKING OUT. IT WAS ALSO FOUND THAT THE NUVASIVE POSTERIOR FIXATION HAD LOOSENED, THEREFORE THE FIXATION AND COMPETITOR'S CAGE WAS REPLACED. NON-UNION WAS OBSERVED AS WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11158625 ↗
• MalfunctionJul 1, 2019Break; Break

  ON (B)(6) 2019, PATIENT UNDERWENT A REVISION PROCEDURE TO REMOVE A PREVIOUSLY IMPLANTED CONSTRUCT AT THE L3 TO L4 VERTEBRAL LEVELS AND TO EXTEND THE CONSTRUCT FROM VERTEBRAL LEVELS L4 TO S1. THE REVISION WENT AS PLANNED WITH NO ISSUES. IN A SUBSEQUENT ROUTINE 4 MONTH FOLLOW UP, IT WAS DISCOVERED THAT THERE WAS A UNILATERAL SCREW BREAKAGE AT THE S1 LEVEL. THE PATIENT IS CURRENTLY ASYMPTOMATIC AND NO REVISION PROCEDURE IS CURRENTLY PLANNED.

  Patient problems: Failure of Implant

  MAUDE report 8750431 ↗
• MalfunctionNov 20, 2018Break; Break

  ON (B)(6) 2018, PATIENT UNDERWENT AN EXTREME LATERAL INTERBODY FUSION PROCEDURE AT T10-T11 LEVELS AND A POSTERIOR SPINAL FUSION PROCEDURE AT T10-PELVIC LEVELS. A POST-OPERATIVE CT IMAGE REVEALED A POSSIBILITY OF SCREW FRACTURE AT T10 AND T11.

  Patient problems: Failure of Implant

  MAUDE report 8090051 ↗
• MalfunctionMar 27, 2018Unintended Movement; Unintended Movement

  ON (B)(6) 2018 PATIENT UNDERWENT A POSTERIOR LUMBAR FUSION PROCEDURE AT L4/5 LEVEL. THE POSITION OF THE IMPLANTS WERE CONFIRMED BY X-RAY IMAGES AND THE SURGERY WAS COMPLETED. REPORTEDLY, TWO DAYS POST-OPERATIVE THE PATIENT'S LEFT LEG BECAME PARALYZED. A CT IMAGE CONFIRMED THAT THE L5 SCREW HAD PENETRATED THE INNER BONE. A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2018 TO REPLACE THE LEFT L5 SCREW WITH A HOOK. PATIENT HAS BEEN REPORTED TO BE DOING WELL POST REVISION PROCEDURE.

  Patient problems: Failure of Implant; Paralysis

  MAUDE report 7374113 ↗
• MalfunctionAug 24, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6) 2017, A PATIENT UNDERWENT POSTERIOR SPINAL FUSION AT THE L3-SAI LEVELS. DURING A FOLLOW-UP, AN X-RAY FILM INDICATED TWO SCREWS HAD LOOSENED AT THE L3 LEVEL. A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2017, TO REMOVE THE LOOSENED SCREWS, ADDED TWO SCREWS AT THE L2 LEVEL AND REPLACE THE RODS. IT WAS ALSO REPORTED NESPLON CABLES WERE ADDED AT THE L2-L3 LEVELS. REPORTEDLY PATIENT IS DOING WELL POST-SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 6819220 ↗