ReLine 13116545Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00887517582508), received between Apr 11, 2018 and Dec 4, 2023 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) 2023:UNDERWENT PLF (POSTEROLATERAL FUSION) BY RELINE WAS PERFORMED AT TH10/L5. (B)(6) 2023: A VERTEBRAL FRACTURE OCCURRED AT TH9 DUE TO ADJACENT SEGMENT DISEASE AND THE PATIENT HAD MILD PARALYSIS FROM UNIDENTIFIED SOURCE, SO THE FIXATION LEVEL WAS EXTENDED TO TH6.

  Patient problems: Bone Fracture(s); Paralysis

  MAUDE report 18257057 ↗
• MalfunctionAug 21, 2022Fracture; Fracture

  IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL POSTERIOR FIXATION PROCEDURE. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY TWO (2) YEARS LATER TO REVISE THE FIXATION CONSTRUCT TO ADDRESS SYMPTOMS AT ADJACENT LEVELS. DURING THE REVISION, IT WAS IDENTIFIED THAT ONE OF THE SCREWS AT THE L3 LEVEL HAD FRACTURED AS ONLY THE PROXIMAL PORTION OF THE SCREW SHANK WAS ABLE TO BE REMOVED. THE DISTAL END OF THE SCREW SHANK WAS UNABLE TO BE REMOVED FROM THE VERTEBRAL BODY BUT WAS REPORTED TO BE COMPLETELY ENCASED IN THE BONE. AS A RESULT, THE FRACTURED PORTION WAS RETAINED BY THE PATIENT AND THE FIXATION CONSTRUCT WAS EXTENDED TO THE LEVEL BELOW. NO FURTHER PATIENT IMPACT WAS REPORTED AND THE PATIENT REPORTEDLY DID NOT EXPERIENCE PAIN OR ANY SYMPTOMS RELATED TO THE FRACTURED SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15263577 ↗
• MalfunctionFeb 4, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2021 A PATIENT UNDERWENT A SPINAL PROCEDURE AT L2/4. ON AN UNKNOWN DATE IT WAS DISCOVERED THAT THE INTERBODY WAS DISPLACED LATERALLY (200061169) DUE TO THE LOOSENING OF A SPINAL SCREW AT L2 OR L4. ON (B)(6) 2022 A REVISION SURGERY WAS CONDUCTED WHERE THE L2 AND L4 SCREWS WERE REPLACED AND COMPETITOR'S INTERBODIES WERE INSERTED AT L4/5/S. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13455713 ↗
• MalfunctionJun 10, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  A REVISION PROCEDURE WAS CONDUCTED ON (B)(6) 2019 DUE TO ADJACENT SEGMENT DISEASE (ASD). AS PER REPORTER THE IMPLANTED SCREWS AT L4 LEVEL HAD BECAME LOOSEN, THIS WAS NOT THE CAUSE OF THE REVISION PROCEDURE BUT, RATHER WAS DISCOVERED DURING THE REVISION. THE PHYSICIAN REPLACED THESE SCREWS WITH NEW ONES AT L4 AND ADDED NEW SCREW & OFFSET CONNECTOR AT ILIUM.

  Patient problems: Failure of Implant

  MAUDE report 10139337 ↗
• InjuryAug 21, 2018Malposition of Device; Malposition of Device

  ON (B)(6) 2018, PATIENT UNDERWENT AN EXTREME LATERAL INTERBODY FUSION PROCEDURE AND POSTERIOR FIXATION ON (B)(6) 2018 AT LEVELS L2-L5 WITH NO REPORTED ISSUES. POST-OPERATIVE EXAMINATION FOUND THE RIGHT SIDE SCREW AT THE L5 LEVEL WAS PLACE INSIDE-OUT INSTEAD OF THE INTENDED OUTSIDE-IN. ON (B)(6) 2018 A REVISION PROCEDURE WAS PERFORMED REPLACING AND REDIRECTING THE SCREW. NO ALLEGED PRODUCT MALFUNCTION REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7803931 ↗
• InjuryJun 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018 PATIENT UNDERWENT A PROCEDURE TO REVISE POSITIONING OF THE LEFT L3, L4 AND ILIAC SCREWS. THE SCREWS AT L2 LEVEL WERE FOUND TO BE LOOSE AND WERE REPLACED, THE SCREWS REMOVED AT L2 WERE REUSED AND PLACED AT L1. ON (B)(6) 2018 IT WAS DISCOVERED THAT THE L1 VERTEBRAL BODY WAS FRACTURED AND A REVISION WAS PERFORMED TO EXTEND THE CONSTRUCT FROM L1 TO T9 LEVEL.

  Patient problems: Bone Fracture(s)

  MAUDE report 7623255 ↗
• MalfunctionApr 11, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6) 2018, A PATIENT UNDERWENT AN EXTREME LATERAL INTERBODY FUSION PROCEDURE AT L2-L5 AND POSTERIOR FUSION PROCEDURE AT L2-ILIAC LEVELS. REPORTEDLY, ON (B)(6) 2018, IT WAS CONFIRMED THAT THE LEFT L3 AND L4 SCREWS HAD PENETRATED THE INNER BONE AND THE LEFT ILIAC SCREW HAD ALSO PENETRATED THE OUTER TABLE OF THE ILIUM. ON (B)(6) 2018 PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEFT L3, L4 AND ILIAC SCREWS WERE REPLACED. SCREWS ON THE L2 LEVEL WERE FOUND TO BE LOOSE AND WERE REPLACED WITH 7.5MM SCREWS, THE SCREWS REMOVED WERE PLACED AT THE L1 LEVEL.

  Patient problems: Failure of Implant

  MAUDE report 7423427 ↗