ReLine 15360500Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00887517510822), received between May 27, 2022 and Feb 16, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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.

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.

• InjuryFeb 16, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL EXTREME LATERAL INTERBODY FUSION PROCEDURE AT UNKNOWN LEVEL(S). SEVEN (7) DAYS LATER, THE PATIENT UNDERWENT A SECONDARY PROCEDURE TO ADD POSTERIOR FIXATION FROM T8 TO SAI. APPROXIMATELY FOUR (4) YEARS LATER, DURING A ROUTINE FOLLOW-UP APPOINTMENT, IT WAS DISCOVERED THAT THE FIXATION RODS ON BOTH SIDES OF THE CONSTRUCT AND ONE ROD TO ROD CONNECTOR WERE FRACTURED NEAR THE L3 VERTEBRAL BODY. THE PATIENT WAS NOTED TO BE ASYMPTOMATIC. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE TO REPLACE THE FRACTURED IMPLANTS AND REINFORCE THE FIXATION CONSTRUCT WITH BILATERAL DUAL RODS. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. REPORT 2 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18723130 ↗
• InjuryFeb 16, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL EXTREME LATERAL INTERBODY FUSION PROCEDURE AT UNKNOWN LEVEL(S). SEVEN (7) DAYS LATER, THE PATIENT UNDERWENT A SECONDARY PROCEDURE TO ADD POSTERIOR FIXATION FROM T8 TO SAI. APPROXIMATELY FOUR (4) YEARS LATER, DURING A ROUTINE FOLLOW-UP APPOINTMENT, IT WAS DISCOVERED THAT THE FIXATION RODS ON BOTH SIDES OF THE CONSTRUCT AND ONE ROD TO ROD CONNECTOR WERE FRACTURED NEAR THE L3 VERTEBRAL BODY. THE PATIENT WAS NOTED TO BE ASYMPTOMATIC. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE TO REPLACE THE FRACTURED IMPLANTS AND REINFORCE THE FIXATION CONSTRUCT WITH BILATERAL DUAL RODS. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. REPORT 1 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18723096 ↗
• InjuryNov 20, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TEN (10) LEVEL POSTERIOR FIXATION PROCEDURE FROM T9 TO S2AI WITH INTERBODY FUSION AT L4/5 AND L5/S1. SUBSEQUENTLY, ON AN UNKNOWN DATE APPROXIMATELY 29 MONTHS POST-OP, THE LEFT FIXATION ROD FRACTURED NEAR L5/S1. A REVISION PROCEDURE WAS PERFORMED TO PLACE A ROD-TO-ROD CONNECTOR AND ADJACENT SEGMENT FIXATION TO REINFORCE THE FRACTURED ROD. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18173818 ↗
• InjuryNov 20, 2023Fracture; Fracture

  IN (B)(6) 2020 A PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE FROM T9- S2 WITH VERTEBRAL SPACERS BEING PLACED AT L4-S. THE SURGERY WAS COMPLETED WITHOUT ISSUE. ON A UNKNOWN DATE IT WAS DISCOVERED THE PATIENT EXPERIENCED A ROD FRACTURE ON THE LEFT SIDE OF THE CONSTRUCT IN-BETWEEN THE L5-S LEVEL. IN (B)(6) 2022 A REVISION OCCURRED WHERE A CONNECTOR WAS PLACED TO REINFORCE THE FRACTURED ROD. THE REVISION WAS COMPLETED WITHOUT ISSUE. (NUVASIVE COMPLAINT (B)(4) ) ON A UNKNOWN DATE IT WAS DISCOVERED THE PATIENT EXPERIENCED ANOTHER ROD FRACTURE THIS TIME ON THE RIGHT SIDE OF THE CONSTRUCT IN-BETWEEN THE L4-L5 LEVEL. ON (B)(6) 2023 AN ADDITIONAL REVISION OCCURRED WHERE A CONNECTOR WAS PLACED TO REINFORCE THE FRACTURED ROD. THE REVISION WAS COMPLETED WITHOUT ISSUE AND THE PATIENT IS REPORTED TO BE DOING WELL POST REVISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18173607 ↗
• MalfunctionMay 27, 2022Fracture; Fracture

  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) 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 14524581 ↗