ReLine 16017580Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00887517554017), received between Mar 22, 2019 and May 27, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (4 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.

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.

• MalfunctionMay 27, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON A UNKNOWN DATE A PATIENT UNDERWENT A VERTEBRAL INTERBODY REPLACEMENT PROCEDURE FROM T9 TO L2 USING A NUVASIVE VERTEBRAL BODY SPACER AND COMPETITORS PRODUCT FOR THE REMAINING PORTION OF THE CONSTRUCT. ON (B)(6) 2022 A REVISION OCCURRED FOR A UNKNOWN REASON TO EXTEND THE CONSTRUCT FROM L4 TO S1 USING NUVASIVE PRODUCTS. ON (B)(6) 2022 AN ADDITIONAL REVISION OCCURRED AS IT WAS DISCOVERED A IMPLANTED ROD FRACTURED AT THE HEAD OF THE RIGHT S1 SCREW. DURING THE REVISION PROCEDURE IT WAS OBSERVED THAT THE SCREWS ON BOTH SIDES OF S1AI AND S2AI WERE FOUND TO HAVE LOOSENING. AS A CONSEQUENCE DURING THE REVISION THEY WERE ALL REPLACED WITH THE SCREWS OF INCREASED SIZE. IT IS UNKNOWN WHETHER THE PATIENT WAS EXPERIENCING ANY ADVERSE CONSEQUENCES AS A RESULT OF THE ROD FRACTURE. THE PATIENT IS DOING WELL POST REVISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14525097 ↗
• MalfunctionMay 27, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON A UNKNOWN DATE A PATIENT UNDERWENT A VERTEBRAL INTERBODY REPLACEMENT PROCEDURE FROM T9 TO L2 USING A NUVASIVE VERTEBRAL BODY SPACER AND COMPETITORS PRODUCT FOR THE REMAINING PORTION OF THE CONSTRUCT. ON (B)(6) 2022 A REVISION OCCURRED FOR A UNKNOWN REASON TO EXTEND THE CONSTRUCT FROM L4 TO S1 USING NUVASIVE PRODUCTS. ON (B)(6) 2022 AN ADDITIONAL REVISION OCCURRED AS IT WAS DISCOVERED A IMPLANTED ROD FRACTURED AT THE HEAD OF THE RIGHT S1 SCREW. DURING THE REVISION PROCEDURE IT WAS OBSERVED THAT THE SCREWS ON BOTH SIDES OF S1AI AND S2AI WERE FOUND TO HAVE LOOSENING. AS A CONSEQUENCE DURING THE REVISION THEY WERE ALL REPLACED WITH THE SCREWS OF INCREASED SIZE. IT IS UNKNOWN WHETHER THE PATIENT WAS EXPERIENCING ANY ADVERSE CONSEQUENCES AS A RESULT OF THE ROD FRACTURE THE PATIENT IS DOING WELL POST REVISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14525052 ↗
• MalfunctionMay 27, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON A UNKNOWN DATE A PATIENT UNDERWENT A VERTEBRAL INTERBODY REPLACEMENT PROCEDURE FROM T9 TO L2 USING A NUVASIVE VERTEBRAL BODY SPACER AND COMPETITORS PRODUCT FOR THE REMAINING PORTION OF THE CONSTRUCT. ON (B)(6) 2022 A REVISION OCCURRED FOR A UNKNOWN REASON TO EXTEND THE CONSTRUCT FROM L4 TO S1 USING NUVASIVE PRODUCTS. ON (B)(6) 2022 AN ADDITIONAL REVISION OCCURRED AS IT WAS DISCOVERED A IMPLANTED ROD FRACTURED AT THE HEAD OF THE RIGHT S1 SCREW. DURING THE REVISION PROCEDURE IT WAS OBSERVED THAT THE SCREWS ON BOTH SIDES OF S1AI AND S2AI WERE FOUND TO HAVE LOOSENING. AS A CONSEQUENCE DURING THE REVISION THEY WERE ALL REPLACED WITH THE SCREWS OF INCREASED SIZE. IT IS UNKNOWN WHETHER THE PATIENT WAS EXPERIENCING ANY ADVERSE CONSEQUENCES AS A RESULT OF THE ROD FRACTURE THE PATIENT IS DOING WELL POST REVISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14524964 ↗
• MalfunctionMay 27, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON A UNKNOWN DATE A PATIENT UNDERWENT A VERTEBRAL INTERBODY REPLACEMENT PROCEDURE FROM T9 TO L2 USING A NUVASIVE VERTEBRAL BODY SPACER AND COMPETITORS PRODUCT FOR THE REMAINING PORTION OF THE CONSTRUCT. ON (B)(6) 2022 A REVISION OCCURRED FOR A UNKNOWN REASON TO EXTEND THE CONSTRUCT FROM L4 TO S1 USING NUVASIVE PRODUCTS. ON (B)(6) 2022 AN ADDITIONAL REVISION OCCURRED AS IT WAS DISCOVERED A IMPLANTED ROD FRACTURED AT THE HEAD OF THE RIGHT S1 SCREW. DURING THE REVISION PROCEDURE IT WAS OBSERVED THAT THE SCREWS ON BOTH SIDES OF S1AI AND S2AI WERE FOUND TO HAVE LOOSENING. AS A CONSEQUENCE DURING THE REVISION THEY WERE ALL REPLACED WITH THE SCREWS OF INCREASED SIZE. IT IS UNKNOWN WHETHER THE PATIENT WAS EXPERIENCING ANY ADVERSE CONSEQUENCES AS A RESULT OF THE ROD FRACTURE THE PATIENT IS DOING WELL POST REVISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14524963 ↗
• MalfunctionMar 22, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6) 2018, A PATIENT UNDERWENT A POSTERIOR SPINAL FUSION AT THE TH5-ILIAC LEVELS. ON (B)(6) 2019, A LOCK SCREW BACK OUT WAS IDENTIFIED. PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2019, WHERE THE SET SCREW WAS REPLACED WITH NO REPORTED ISSUES. NOT PATIENT INJURY REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 8443984 ↗