ReLine 11104055Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00887517596246), received between Oct 9, 2016 and Jan 13, 2026 — classified as 1 death, 2 injuries, 9 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026Migration or Expulsion of Device

  IT WAS REPORTED THAT THE LEFT AND RIGHT SPINAL RODS WERE SET IN (B)(6) 2021 BROKE BETWEEN L1/L2 VERTEBRAE. SUPPLEMENTAL RODS WERE INSTALLED ON BOTH SIDES FOR REINFORCEMENT, BUT THE RODS LATER CAME LOOSE FROM THE LEFT AND RIGHT RODS FROM THE CONNECTOR ON THE CRANIAL SIDE. THE SURGEON PERFORMED SURGERY AGAIN ON (B)(6) 2025, TO REPLACE SPINAL SCREWS AND SPINAL RODS. WE DO NOT RECEIVE ANY OTHER ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24057185 ↗
• InjuryNov 18, 2025Migration; Migration

  IT WAS REPORTED THAT A REVISION OCCURRED DUE TO THE CONNECTOR DETACHING FROM THE ROD. ANOTHER REVISION OCCURRED A FEW MONTHS LATER DUE TO THE SAME FAILURE MODE.

  Patient problems: Failure of Implant

  MAUDE report 23582166 ↗
• MalfunctionNov 18, 2022Misconnection; Misconnection

  ON (B)(6) 2022 A PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE ON UNKNOWN LEVELS OF THE SPINE. THE SURGERY WAS COMPLETED WITHOUT ISSUE. ON A UNKNOW DATE IT WAS DISCOVERED THAT A IMPLANTED ROD DETACHED FROM ROTATING CONNECTOR. IT IS UNKNOW IF ANY ADVERSE CONSEQUENCES WERE BEING EXPERIENCED AS A RESULT OF THE DEVICE FAILURE. ON (B)(6) 2022 THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE FAILED ROTATING CONNECTOR WAS REMOVED AND REPLACED WITH AN ADJACENT SEGMENT FIXATION CONNECTOR. THE PATIENT IS REPORTED TO BE DOING WELL POST REVISION PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15825915 ↗
• InjuryNov 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021 A PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE FROM T10 TO S2AI. THE SURGERY WAS COMPLETED WITHOUT ISSUE BUT THE FOLLOWING DAY THE PATIENT HAD PAIN IN HIS RIGHT KNEE AND COULD NOT KNEEL ON HIS RIGHT LEG. A HEMATOMA WAS FOUND AROUND L3-L5 AND A REVISION OCCURRED TO ADDRESS IT. THE ROOT CAUSE OF THE HEMATOMA IS REPORTED TO BE UNKNOWN. THE PATIENT STATUS HAS BEEN IMPROVING BUT HE IS STILL EXPERIENCING TROUBLE MOVING HIS RIGHT KNEE.

  Patient problems: Hematoma

  MAUDE report 12838370 ↗
• MalfunctionApr 13, 2021Fracture; Fracture

  ON AN UNKNOWN DATE APPROXIMATELY 2 YEARS AGO, A PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE AT L2/S2. ON ANOTHER DAY AS A SECONDARY SURGERY THE FIXATION LEVEL WAS EXTENDED TO T10 AND OH CONNECTORS WERE INSTALLED AT L2/3. IN (B)(6) 2021 THE PATIENT RECEIVED AN X-RAY DUE TO THE SOUND OF AN IMPLANTED ROD BREAKING AND THE X-RAY REVEALED A ROD OR OH CONNECTOR FRACTURED. REPORTEDLY FUSION HAS COMPLETED AND NO REVISION SURGERY IS PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11655625 ↗
• MalfunctionMar 8, 2021Separation Problem; Separation Problem

  ON (B)(6) 2020 A CONSTRUCT EXTENSION WAS PERFORMED TO EXTEND A PREVIOUS T10-S2 UP TO T3 DUE TO ADJACENT SEGMENT DISORDER. DURING THE REVISION SURGERY, ROTATING CONNECTORS WERE UTILIZED ON THE LEFT T10/11 AND RIGHT T11/12. ON AN UNKNOWN DATE, AN X-RAY WAS TAKEN DUE TO THE PATIENT EXPERIENCING BACK PAIN. THE X-RAY REVEALED A LOCK SCREW ON THE CONNECTOR INSTALLED AT LEFT T10/11 CAME OFF AND A ROD SEPARATION OCCURRED AT THE CONNECTOR INSTALLED AT THE RIGHT T11/12. ON (B)(6) 2021 A REVISION SURGERY WAS PERFORMED WERE THE TWO CONNECTORS AND TWO RODS WERE REMOVED AND BOTH SIDES WERE RE-FIXED WITH A SINGLE ROD. BONE FUSION WAS FOUND TO BE COMPLETED AND THERE WAS DISCOLORATION OF TISSUE FOUND AT T9/10.

  Patient problems: Pain

  MAUDE report 11436390 ↗
• MalfunctionJun 10, 2020Disconnection; Disconnection

  A PATIENT UNDERWENT A SPINAL PROCEDURE ON UNKNOWN LEVELS IN (B)(6) OF 2019. AS PER REPORTER, PATIENT BEGAN TO EXPERIENCE PAIN AND DURING A ROUTINE POST-OP FOLLOW UP IT WAS DISCOVERED THERE WAS A LOOSE CONNECTOR PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2020.

  Patient problems: Failure of Implant

  MAUDE report 10138798 ↗
• MalfunctionJan 15, 2019Unintended Movement; Unintended Movement

  ON (B)(6), A POST-OPERATIVE RADIOGRAPH REVEALED KYPHOTIC DEFORMITY DUE LOOSE SET SCREWS AND O-H CONNECTORS. ON (B)(6) 2018 PATIENT UNDERWENT A REVISION PROCEDURE WHERE BOTH SCREWS AT L1 LEVEL WERE REMOVED, A BALLOON KYPHOPLASTY WAS PERFORMED AND CONSTRUCT WAS EXTENDED. AS PER REPORTER SET SCREWS WERE CONFIRMED LOOSE DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Failure of Implant

  MAUDE report 8251218 ↗
• MalfunctionNov 16, 2017Break; Break

  ON (B)(6) 2017, A SURGEON INFORMED A NUVASIVE SALES REPRESENTATIVE THAT THE RELINE-O CONN, REPORTEDLY BROKE OR HAD PULLED APART. A REVISION PROCEDURE HAS NOT BEEN SCHEDULED. NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 7036893 ↗
• MalfunctionOct 19, 2017Break; Break

  A PATIENT UNDERWENT A SPINAL FUSION PROCEDURE AT T11-L1 AND L4-5 LEVELS USING NON NUVASIVE PRODUCTS. POST-OPERATIVELY, CONNECTOR AT L4 WAS SEPARATED FROM THE ROD. ON (B)(46) 2017, PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE CONNECTOR WAS REPLACED WITH A NUVASIVE RELINE O-H CONNECTOR. SUBSEQUENTLY, THE LOCK SCREW OF THE RELINE O-H CONNECTOR SEPARATED. ON (B)(6) 2017, A REVISION PROCEDURE WAS PERFORMED TO REPLACE THE LOCK SCREW.

  Patient problems: Failure of Implant

  MAUDE report 6961935 ↗
• DeathOct 31, 2016Insufficient Device Problem Information; Insufficient Device Problem Information

  A FEMALE PATIENT (AGE UNKNOWN) UNDERWENT A SPINAL PROCEDURE INVOLVING POSTERIOR FIXATION ON (B)(6) 2015. ON (B)(6) 2015, THE PATIENT WAS REPORTED TO HAVE EXPIRED FOLLOWING A HEMOTHORAX EVENT. NO OTHER INFORMATION IS KNOWN.

  Patient problems: Death; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 6068434 ↗
• MalfunctionOct 9, 2016Mechanical Problem; Mechanical Problem

  A MALE PATIENT (AGE UNKNOWN) RECEIVED AN EXTENSION OF A CONSTRUCT PREVIOUSLY IMPLANTED (DATE UNKNOWN) DUE TO CONTINUED DEGENERATION/INSTABILITY ON (B)(6) 2016. ON (B)(6) 2016, A REVISION SURGERY WAS AGAIN PERFORMED AFTER RADIOGRAPHS INDICATED A CONNECTOR USED TO JOIN THE TWO SEGMENTS HAD SEPARATED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 6013258 ↗