ReLine 13550000Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00887517551702), received between Jul 25, 2016 and Feb 25, 2026 — classified as 4 injuries, 51 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (19 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 25 most recent of 55 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2026Fracture

  IT WAS REPORTED THAT THE PATIENT HAD INDEX L4-S1 MIS TLIF (B)(6) 2026. TWO WEEKS POST-OP, PATIENT REPORTED HE ¿BENT OVER AND HEARD A POP¿. UPON X-RAY EXAMINATION, THE RELINE MAS MODULAR SCREW HEAD DISASSOCIATED FROM THE RELINE MAS MODULAR SCREW SHANK. THE CONTRALATERAL SET SCREW AT L4 WAS ALSO LOOSE. SCREW REPLACEMENT REVISION TOOK PLACE ON.

  Patient problems: Failure of Implant

  MAUDE report 24447093 ↗
• InjuryMar 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2024 A PATIENT UNDERWENT A ONE-LEVEL POSTERIOR FIXATION. THE SURGERY WAS COMPLETED WITH NO ISSUE. ON (B)(6) 2025, IT WAS DISCOVERED DURING A ROUTINE FOLLOW UP VIA IMAGING THAT THE ROD HAD SEPARATED FROM THE LOCK SCREW IN THE ASSOCIATED TULIP. THE ROD DISASSOCIATION RESULTED IN FOCAL KYPHOSIS AROUND THE CONSTRUCT SITE. A REVISION PROCEDURE WAS CONDUCTED ON (B)(6) 2025 IN WHICH THE SEPARATED ROD WAS REPLACED AND THE CONSTRUCT WAS EXTENDED FROM L2 TO PELVIS. THE REVISION PROCEDURE WAS COMPLETED WITHOUT ISSUE AND THE PATIENT WAS REPORTED TO BE DOING WELL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21646289 ↗
• MalfunctionSep 27, 2024Mechanical Problem; Migration or Expulsion of Device; Mechanical Problem; Migration or Expulsion of Device

  WE HAD X4 INSTANCES OF POST-OPERATIVE LOCK SCREW DISASSOCIATION IN DEGENERATIVE CASES (1, 2, AND 3 LEVELS) O REDUCTION WAS PERFORMED USING THE LOCK SCREW AND EXTENDED TABS TO PUSH THE ROD DOWN. NO CROSS-THREADING, EXCESSIVE TORQUE (INCREASED TORSIONAL RESISTANCE), OR TULIP SPLAY WAS OBSERVED DURING INSERTION OR FINAL TIGHTENING. TORQUE T-HANDLES HAVE NEVER BEEN SENT BACK TO MEMPHIS FOR CALIBRATION, THE HANDLES DID NOT APPEAR TO IMPART SUBSTANTIALLY MORE OR LESS TORQUE THAN THE NORMAL. REVISIONS WERE COMPLETED WITH NO PROVIDED DETAILS AND EX-PLANTS WERE DISCARDED BY THE USER FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20328677 ↗
• MalfunctionSep 27, 2024Mechanical Problem; Migration or Expulsion of Device; Mechanical Problem; Migration or Expulsion of Device

  WE HAD X4 INSTANCES OF POST-OPERATIVE LOCK SCREW DISASSOCIATION IN DEGENERATIVE CASES (1, 2, AND 3 LEVELS) O REDUCTION WAS PERFORMED USING THE LOCK SCREW AND EXTENDED TABS TO PUSH THE ROD DOWN. NO CROSS-THREADING, EXCESSIVE TORQUE (INCREASED TORSIONAL RESISTANCE), OR TULIP SPLAY WAS OBSERVED DURING INSERTION OR FINAL TIGHTENING. TORQUE T-HANDLES HAVE NEVER BEEN SENT BACK TO MEMPHIS FOR CALIBRATION, THE HANDLES DID NOT APPEAR TO IMPART SUBSTANTIALLY MORE OR LESS TORQUE THAN THE NORMAL. REVISIONS WERE COMPLETED WITH NO PROVIDED DETAILS AND EX-PLANTS WERE DISCARDED BY THE USER FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20328676 ↗
• MalfunctionSep 27, 2024Mechanical Problem; Migration or Expulsion of Device; Mechanical Problem; Migration or Expulsion of Device

  WE HAD X4 INSTANCES OF POST-OPERATIVE LOCK SCREW DISASSOCIATION IN DEGENERATIVE CASES (1, 2, AND 3 LEVELS) O REDUCTION WAS PERFORMED USING THE LOCK SCREW AND EXTENDED TABS TO PUSH THE ROD DOWN. NO CROSS-THREADING, EXCESSIVE TORQUE (INCREASED TORSIONAL RESISTANCE), OR TULIP SPLAY WAS OBSERVED DURING INSERTION OR FINAL TIGHTENING. TORQUE T-HANDLES HAVE NEVER BEEN SENT BACK TO MEMPHIS FOR CALIBRATION, THE HANDLES DID NOT APPEAR TO IMPART SUBSTANTIALLY MORE OR LESS TORQUE THAN THE NORMAL. REVISIONS WERE COMPLETED WITH NO PROVIDED DETAILS AND EX-PLANTS WERE DISCARDED BY THE USER FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20328631 ↗
• MalfunctionSep 27, 2024Mechanical Problem; Migration or Expulsion of Device; Mechanical Problem; Migration or Expulsion of Device

  WE HAD X4 INSTANCES OF POST-OPERATIVE LOCK SCREW DISASSOCIATION IN DEGENERATIVE CASES (1, 2, AND 3 LEVELS) O REDUCTION WAS PERFORMED USING THE LOCK SCREW AND EXTENDED TABS TO PUSH THE ROD DOWN. NO CROSS-THREADING, EXCESSIVE TORQUE (INCREASED TORSIONAL RESISTANCE), OR TULIP SPLAY WAS OBSERVED DURING INSERTION OR FINAL TIGHTENING. TORQUE T-HANDLES HAVE NEVER BEEN SENT BACK TO MEMPHIS FOR CALIBRATION, THE HANDLES DID NOT APPEAR TO IMPART SUBSTANTIALLY MORE OR LESS TORQUE THAN THE NORMAL. REVISIONS WERE COMPLETED WITH NO PROVIDED DETAILS AND EX-PLANTS WERE DISCARDED BY THE USER FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20328623 ↗
• MalfunctionSep 10, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2024 A PATIENT UNDERWENT A TRANSFORAMINAL INTERBODY LUMBAR FUSION FROM L3-L4 WITH POSTERIOR FIXATION BEING PLACED FROM L2-L5. ON (B)(6) 2024 A REVISION SURGERY OCCURRED DUE TO LOOSENING OF LOCKSCREW AT THE RIGHT L2 LEVEL AND MALPOSITIONING OF THE RIGHT L5 PEDICLE SCREW. DURING THE PROCEDURE IT WAS ALSO DISCOVERED THE RIGHT L3 LOCK SCREW WAS LOOSE. THE LEFT L2 AND LEFT L5 PEDICLE SCREWS WERE REPLACED AND THE LOOSENED LOCK SCREWS WERE REINSERTED AND RETIGHTENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20182277 ↗
• MalfunctionAug 22, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2024 A PATIENT UNDERWENT A TRANSFORAMINAL INTERBODY LUMBAR FUSION FROM L3-L4 WITH POSTERIOR FIXATION BEING PLACED FROM L2-L5. ON (B)(6) 2024 A REVISION SURGERY OCCURRED DUE TO LOOSENING OF LOCKSCREW AT THE RIGHT L2 LEVEL AND MALPOSITIONING OF THE RIGHT L5 PEDICLE SCREW. DURING THE PROCEDURE IT WAS ALSO DISCOVERED THE RIGHT L3 LOCK SCREW WAS LOOSE. THE LEFT L2 AND LEFT L5 PEDICLE SCREWS WERE REPLACED AND THE LOOSENED LOCK SCREWS WERE REINSERTED AND RETIGHTENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20028266 ↗
• InjuryNov 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL ONE (1) LEVEL POSTERIOR FIXATION PROCEDURE FROM L5 TO S1. SUBSEQUENTLY, DURING A ROUTINE EXAMINATION ON AN UNKNOWN DATE, THE L5 LOCK SCREW WAS FOUND TO BE DISLODGED FROM THE TULIP ON A RADIOGRAPH. THE PATIENT REPORTED NO PAIN OR OTHER SYMPTOMS. A REVISION PROCEDURE WAS PERFORMED APPROXIMATELY TWO (2) WEEKS LATER TO REPLACE THE DISLODGED LOCK SCREW AND RETIGHTEN THE OTHER THREE LOCK SCREWS. INFORMATION REGARDING THE PATIENT'S POST-OP ACTIVITY LEVELS AND IF ANY TRAUMA OCCURRED WAS REQUESTED BUT NOT AVAILABLE. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18116252 ↗
• InjuryMay 25, 2023Detachment of Device or Device Component; Expulsion; Detachment of Device or Device Component; Expulsion

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17004206 ↗
• MalfunctionApr 12, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6) 2023 A PATIENT UNDERWENT AN ANTERIOR LUMBAR INTERBODY FUSION WITH POSTERIOR FIXATION FROM L5 TO S1. THE SURGERY WAS COMPLETED WITHOUT ISSUE. ON (B)(6) 2023 IT WAS DISCOVERED DURING A FOLLOW UP APPOINTMENT THAT THE INTERBODY HAD MIGRATED ANTERIORLY (B)(4) AND ONE OF THE SUPERIOR LOCK SCREWS APPEARED TO HAVE BACKED OUT. THE PATIENT WAS REPORTED TO HAVE HAD NO ADVERSE CONSEQUENCES AS A RESULT OF THE MIGRATIONS. ON (B)(6)2023 A REVISION OCCURRED WHERE THE MIGRATED INTERBODY AND BACKED OUT LOCK SCREW WERE REPLACED. THE PATIENT IS REPORTED TO BE DOING WELL POST REVISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16725895 ↗
• MalfunctionOct 11, 2022Migration or Expulsion of Device; Detachment of Device or Device Component; Migration or Expulsion of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE. SUBSEQUENTLY, DURING A ROUTINE FOLLOW UP APPROXIMATELY THREE (3) MONTHS LATER, IT WAS IDENTIFIED THAT THE LOCK SCREW OF THE ROD-TO-ROD CONNECTOR AT L4/L5 HAD LOOSENED. THE PATIENT NOTED EXPERIENCING SYMPTOMS OF PAIN IN ADDITION TO THE FEELING OF LOOSE COMPONENTS. A REVISION PROCEDURE WAS PERFORMED APPROXIMATELY SIX (6) MONTHS AFTER THE INITIAL PROCEDURE TO REMOVE AND REPLACE THE CONNECTOR AND LOCK SCREW. NO FURTHER PATIENT IMPACT WAS REPORTED. THE PATIENT IS REPORTED TO BE DOING WELL POST-REVISION PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE. REPORT 1 OF 2.

  Patient problems: Pain

  MAUDE report 15577497 ↗
• MalfunctionJul 11, 2022Separation Problem; Separation Problem

  ON THE (B)(6) 2022 A PATIENT REQUIRED A SECOND REVISION DUE TO OTHER MANUFACTURER'S 5.5 ROD SEPARATION AT ILIAC. IMAGING SHOWED THE LOCK SCREW WAS STILL ENGAGED TO THE ILIAC SCREW TULIP. SURGEON NOTED LOCK SCREW WAS SITTING FLUSH IN THE TULIP HEAD. LOCK SCREW WAS REPLACED, AN ADDITIONAL ILIAC SCREW WAS PLACED ON THE SAME SIDE (L) UTILIZING A 30MM OFFSET CONNECTOR, REPLACED OTHER MANUFACTURER'S ROD WITH A NUVASIVE 5.5MM COCR ROD AND BENT THE ROD OVER HANG TO CREATE A ¿HOOK¿ TO STOP ANOTHER SLIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14982684 ↗
• MalfunctionJun 9, 2022Migration or Expulsion of Device; Detachment of Device or Device Component; Migration or Expulsion of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL ONE (1) LEVEL POSTERIOR FIXATION PROCEDURE AT L4/5 USING AN ANTERIOR TLIF INTERBODY CAGE AND POSTERIOR FIXATION. SUBSEQUENTLY, ON AN UNKNOWN DATE, THE PATIENT REPORTED SYMPTOMS OF PAIN. UPON EXAMINATION, IT WAS IDENTIFIED THAT THE LOCK SCREW WAS FOUND TO BE LOOSE AND THE INTERBODY CAGE HAD MIGRATED LATERALLY AND WAS OUTSIDE OF THE DISC SPACE. THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY TEN (10) WEEKS AFTER THE INITIAL SURGERY TO REMOVE THE EXPULSED LOCK SCREW AND MIGRATED DEVICE AND EXTEND THE FIXATION CONSTRUCT FROM L3 TO S2. NO FURTHER PATIENT IMPACT WAS REPORTED.

  Patient problems: Pain

  MAUDE report 14648629 ↗
• MalfunctionJan 28, 2022Expulsion; Expulsion

  ON (B)(6) 2021 A PATIENT UNDERWENT A POSTERIOR FIXATION SPINAL PROCEDURE FROM L2 TO L5 THAT WAS COMPLETED WITHOUT INCIDENT. ON (B)(6) 2022 DURING A ROUTINE ONE MONTH FOLLOW IT WAS DISCOVERED BY RADIOGRAPH THAT THE LOCK SCREW ON THE LEFT L5 LEVEL HAD COMPLETELY EXPELLED AND WAS FLOATING FREELY IN THE PATIENTS TISSUE. THE PATIENT IS ASYMPTOMATIC. CROSS THREADING WAS REPORTED TO BE THE SUSPECTED CAUSE. A REVISION WAS REPORTED TO HAVE TAKEN PLACE BUT NO INFORMATION FROM THE REVISION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13386048 ↗
• MalfunctionJan 6, 2022Expulsion; Expulsion

  ON (B)(6) 2020 A PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE ON UNKNOWN LEVELS OF THE SPINE. DURING A SIX WEEK FOLLOW UP APPOINTMENT IT WAS DISCOVERED VIA RADIOGRAPH SCAN THAT THE PATIENT HAD ALREADY LOST SOME CORRECTION AND ONE OF THE SET SCREW HAD EXPELLED AND WAS FLOATING FREELY IN THE PATIENT. THE PATIENT IS ASYMPTOMATIC AND NO REVISION HAS OCCURRED OR IS PLANNED AT THIS DATE. THE SURGEON IS CONTINUING TO MONITOR THE PATIENTS STATUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13176854 ↗
• MalfunctionJan 6, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON (B)(6) 2021 A PATIENT UNDERWENT A SPONDYLECTOMY PROCEDURE AT L3 WITH POSTERIOR FIXATION FROM T12 TO L5. THE SURGERY WAS COMPLETED WITHOUT ISSUE. WITHIN 1-2 HOURS AFTER THE SURGERY THE PHYSICIAN STATED THAT THE CONSTRUCT LOCK SCREW WERE NOT TORQUED OFF. FOR UNKNOWN REASONS DURING THE INITIAL PROCEDURE THE SCREWS WERE ONLY HAND TIGHTENED. ON (B)(6) 2021 A REVISION OCCURRED WERE THE SCREWS WERE ALL RETIGHTENED WITH A TORQUE HANDLE. THE PATIENT IS/WAS ASYMPTOMATIC AND IT REPORTED TO BE RECOVERING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13176294 ↗
• MalfunctionDec 15, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON UNKNOWN DATE A PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE ON UNKNOWN LEVELS OF THE SPINE. ON A UNKNOWN DATE IT WAS DISCOVERED DURING A ROUTINE FOLLOW UP TWO OF THE CONNECTORS LOCK SCREWS HAD LOOSENED. ON A UNKNOWN DATE A REVISION OCCURRED TO ADDRESS THE LOOSENED SCREWS. IT IS UNKNOWN WHAT OCCURRED DURING THAT REVISION. THE PATIENT WAS REPORTED TO HAVE RECOVERED WELL POST REVISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13013919 ↗
• MalfunctionDec 15, 2021Expulsion; Noise, Audible; Expulsion; Noise, Audible

  ON A UNKNOWN DATE THE PATIENT WAS REPORTED TO BE HEARING THE SOUND OF METAL COMING FROM HIS BACK. IT WAS THEN DISCOVERED DURING A FOLLOW WITH HIS PHYSICIAN THAT TWO CONNECTOR LOCK SCREWS HAD COMPLETELY EXPELLED FROM THE CONNECTOR AND WERE FLOATING LOOSELY IN THE PATIENT. ON A UNKNOWN DATE A REVISION OCCURRED TO ADDRESS THE LOOSENED SCREWS. DURING THE REVISION THE EXPELLED LOCK SCREW WERE REPLACED. THE PATIENT IS REPORTED TO BE DOING WELL POST REVISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13012579 ↗
• MalfunctionDec 15, 2021Expulsion; Noise, Audible; Expulsion; Noise, Audible

  ON A UNKNOWN DATE THE PATIENT WAS REPORTED TO BE HEARING THE SOUND OF METAL COMING FROM HIS BACK. IT WAS THEN DISCOVERED DURING A FOLLOW WITH HIS PHYSICIAN THAT TWO CONNECTOR LOCK SCREWS HAD COMPLETELY EXPELLED FROM THE CONNECTOR AND WERE FLOATING LOOSELY IN THE PATIENT. ON A UNKNOWN DATE A REVISION OCCURRED TO ADDRESS THE LOOSENED SCREWS. DURING THE REVISION THE EXPELLED LOCK SCREW WERE REPLACED. THE PATIENT IS REPORTED TO BE DOING WELL POST REVISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13011877 ↗
• MalfunctionDec 15, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON UNKNOWN DATE A PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE ON UNKNOWN LEVELS OF THE SPINE. ON A UNKNOWN DATE IT WAS DISCOVERED DURING A ROUTINE FOLLOW UP TWO OF THE CONNECTORS LOCK SCREWS HAD LOOSENED. ON A UNKNOWN DATE A REVISION OCCURRED TO ADDRESS THE LOOSENED SCREWS. IT IS UNKNOWN WHAT OCCURRED DURING THAT REVISION. THE PATIENT WAS REPORTED TO HAVE RECOVERED WELL POST REVISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13011695 ↗
• MalfunctionOct 6, 2021Migration or Expulsion of Device; Migration; Migration or Expulsion of Device; Migration

  NEW AND UPDATED INFORMATION LISTED ON H10.

  Patient problems: Pain

  MAUDE report 12584270 ↗
• MalfunctionOct 6, 2021Migration or Expulsion of Device; Migration; Migration or Expulsion of Device; Migration

  NEW AND UPDATED INFORMATION LISTED ON H10NEW AND UPDATED INFORMATION LISTED ON H10.

  Patient problems: Pain

  MAUDE report 12584220 ↗
• MalfunctionOct 6, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6) 2021 A (B)(6) PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE ON UNKNOWN LEVELS OF THE SPINE. A FEW DAYS FOLLOWING THE SURGERY THE PATIENT WAS REPORTED TO BE EXPERIENCING ADDITIONAL PAIN. ON A (B)(6) 2021 IT WAS DISCOVERED VIA RADIOGRAPH THAT X2 OF THE IMPLANTED LOCK SCREWS BACKED OUT ON THE LEFT L3 AND L4 SIDE OF THE CONSTRUCT. ON A (B)(6) 2021 A REVISION OCCURRED WHERE THE TWO BACKED OUT LOCK SCREWS WERE REPLACED. DURING THE PROCEDURE IT WAS ALSO DISCOVERED THAT THE LOCK SCREWS AT L1 AND T12 WERE LOOSE AND WERE SITTING PROUD. THESE WERE ALSO REPLACED DURING THE REVISION. THE PATIENTS POST OP STATUS IS CURRENTLY UNKNOWN. (RELATED COMPLAINTS (B)(4))

  Patient problems: Pain

  MAUDE report 12584143 ↗
• MalfunctionOct 6, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  NEW AND UPDATED INFORMATION LISTED ON H10.

  Patient problems: Pain

  MAUDE report 12583916 ↗