ReLine 15455500Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00887517594204), received between Dec 8, 2016 and Jan 7, 2026 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Fracture” (10 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 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2026Fracture

  IT WAS REPORTED THAT ON (B)(6) 2019 THE SURGEON INSERTED COROENT XL PEEK CAGE INTO L1~L5 BY XLIF, AND ANOTHER BRAND SPINAL CAGE INTO L5/S1 BY PLIF. THEN ON (B)(6) 2019 THE SURGEON FIXED SPINE FROM TH10 TO S2 ALAR ILIAC. THE SPINAL ROD WAS FRACTURED AT THE FOLLOWING SITES, BUT WE COULD NOT OBTAIN INFORMATION WHEN THE ROD FRACTURED: TH12/L1; RIGHT SIDE AND LEFT SIDE L4/L5: RIGHT SIDE AND L5/L1 RIGHT SIDE. THEN ON (B)(6) 2025 THE SURGEON PERFORMED REVISION SURGERY. THEN ON (B)(6) 2025 WE OBTAINED INFORMATION THAT THE PATIENT HAD BEEN DISCHARGED FROM THE HOSPITAL. WE DID NOT OBTAIN ANY OTHER PHOTOGRAPHS AND REVISED IMPLANTS FROM THE HOSPITAL. AND WE DO NOT RECEIVE ANY OTHER ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23989554 ↗
• MalfunctionMay 24, 2024Fracture; Fracture

  ON (B)(6) 2023 A PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE FROM T8 TO S2AI. THE SURGERY WAS COMPLETED WITHOUT ISSUE. ON A UNKNOWN DATE, A ROD IN THE CONSTRUCT WAS REPORTED TO HAVE FRACTURED ON THE LEFT SIDE AT S1/SAI. ON (B)(6) 2024 A REVISION SURGERY WAS CONDUCTED TO REMOVE AND REPLACE THE FRACTURED ROD. ADDITIONALLY, AN ILIAC SCREW WAS ADDED ON THE LEFT, AND RODS WERE ADDED, ONE EACH LATERALLY AND MEDIALLY TO REINFORCE THE CONSTRUCT. THE REVISION SURGERY WAS COMPLETED WITHOUT ISSUE WITH NO ADVERSE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19392220 ↗
• InjuryJul 29, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL NINE (9) LEVEL FIXATION PROCEDURE WITH INTERBODY DEVICES PLACED AT L1 TO L5 AND POSTERIOR FIXATION FROM T9 TO ILIAC. SUBSEQUENTLY, RADIOGRAPHS OBTAINED APPROXIMATELY 17 MONTHS AFTER THE INITIAL PROCEDURE REVEALED FRACTURE OF THE RIGHT POSTERIOR FIXATION ROD AT THE L5/S1 SPACE. AN ADDITIONAL PROCEDURE WAS PERFORMED TWO (2) WEEKS LATER TO REINFORCE THE L5/S1 VERTEBRAE WITH ADDITIONAL ROD FIXATION. NO FURTHER PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15136586 ↗
• MalfunctionMay 11, 2021Fracture; Fracture

  ON (B)(6) 2018 A PATIENT UNDERWENT A SPINAL PROCEDURE. ON (B)(6) 2021 THE PATIENT REPORTED HEARING A SOUND WHEN BENDING DOWN. ON (B)(6) 2021 AN X-RAY REVEALED A ROD FRACTURE AT L4/5. ON (B)(6) 2021 A REVISION SURGERY WAS PERFORMED AND BONE FUSION WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11808538 ↗
• MalfunctionApr 9, 2021Fracture; Fracture

  A PATIENT UNDERWENT A SPINAL PROCEDURE TO ADDRESS KYPHOSIS FROM T10 TO S2A1 WITH A SPACER CAGE BEING PLACED BETWEEN L5/S. ON AN UNKNOWN DATE THE PATIENT HEARD A SOUND AND FOLLOWED UP ON (B)(6) 2021 WHERE RADIOGRAPHS CONFIRMED THAT THE LEFT ROD HAD FRACTURED AROUND L5/S1 AND A SCREW HEAD HAD FRACTURED AT S2A1. THE PATIENT UNDERWENT REOPERATION ON (B)(6) 2021 WHERE THE FRACTURED SCREW AND ROD WERE REPLACED AND AN EXTRA ROD WAS ADDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11642824 ↗
• MalfunctionFeb 6, 2021Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2020, THE PATIENT UNDERWENT A SPINAL PROCEDURE WITH RELINE PRODUCTS AT L2/S2AI. ON (B)(6) 2020, IT WAS DISCOVERED DURING ROUTINE FOLLOW UP X-RAY THAT RODS AT L4/5 FRACTURED. ON (B)(6) 2020, A REVISION SURGERY WAS PERFORMED. IN THE REVISION SURGERY, SACRAL SCREWS HAD LOOSENED, SO THE SCREWS WERE REMOVED AND INSERTED ONE SIZE LARGER SCREWS INSTEAD, AND THE FRACTURED RODS WERE REPLACED TO NEW TI RODS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11290242 ↗
• MalfunctionMay 29, 2020Fracture; Fracture

  ON UNKNOWN DATE, AN X-RAY REVEALED THAT AN IMPLANTED RELINE ROD BROKE AT NEAR L5 LEVEL. AS PER REPORTER THE ROD WAS PLANNED TO BE REPLACED ON (B)(6) 2020.

  Patient problems: Failure of Implant

  MAUDE report 10099837 ↗
• InjuryDec 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECEIVED INFORMATION STATING PATIENT WAS EXPERIENCING SEVERE ALLERGIC REACTIONS POST OPERATIVE. INQUIRY RECEIVED, BREAKDOWN OF THE METALS IN EACH OF THE PIECES UTILIZED IN THE PATIENT'S PROCEDURE.

  Patient problems: Reaction; Seizures

  MAUDE report 9497776 ↗
• MalfunctionAug 8, 2018Break; Break

  ON (B)(6) 2018, PATIENT UNDERWENT A SPINAL FUSION PROCEDURE AT T8 TO PELVIS LEVELS. A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2018 DUE TO BROKEN RODS. NO PATIENT INJURY HAS BEEN REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 7762908 ↗
• MalfunctionDec 11, 2017Fracture; Fracture

  ON (B)(6) 2017 A PATIENT UNDERWENT A POSTERIOR SPINAL FUSION PROCEDURE AT L4-S1 LEVELS. LATE (B)(6), THE PATIENT EXPERIENCED PAIN, RADIOGRAPHS SHOWED A FRACTURED ROD. ON (B)(6) 2017 A REVISION PROCEDURE TOOK PLACE REPLACING THE ROD AND REINFORCING THE CONSTRUCT. NO PATIENT INJURY REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 7106619 ↗
• MalfunctionJun 6, 2017Fracture; Fracture

  ON (B)(6) 2016, A (B)(6) YEAR-OLD MALE PATIENT UNDERWENT POSTERIOR SPINAL FUSION AT THE T10-S2 LEVELS. THE ROD REPORTEDLY FRACTURED ON BOTH SIDES AT THE L4/5 LEVEL. ON (B)(6) 2017 REVISION SURGERY OCCURRED TO REPLACE THE FRACTURED ROD. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 6615991 ↗
• MalfunctionDec 8, 2016Fracture; Fracture

  ON (B)(6) 2016 A PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE. ON (B)(6) 2016 A REVISION PROCEDURE TOOK PLACE TO REPLACE A FRACTURED ROD AT L4/5. NO PATIENT INJURY REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 6155797 ↗