ReLine 13600000Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00887517551719), received between Jan 29, 2018 and Feb 26, 2026 — classified as 2 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Migration” (8 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2026Material Separation

  IT WAS REPORTED THAT A 6.0 RELINE SET SCREW FAILED WHILE BEING TIGHTENED DURING AN AIS SCOLI FUSION CASE WITH DR. JON ODA. DR. ODA WAS PROVISIONALLY TIGHTENING THE SET SCREW INTO A HOOK AT THE TOP OF THE CONSTRUCT WHEN HE INDICATED IT FELT STRANGE. UPON REMOVAL A LONG THREAD OF METAL HAD SHEARED OFF BUT WAS STILL ATTACHED TO THE SET SCREW. THIS EXTENDED SURGERY BY APPROX. 30 MINUTES AS THE DOCTOR ATTEMPTED TO REDUCE THE ROD TO THE HOOK AGAIN AND INSERT NEW SET SCREW.

  Patient problems: Failure of Implant

  MAUDE report 24462118 ↗
• MalfunctionMar 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2023 A PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE FROM C7 TO T9. THE SURGERY WAS COMPLETED WITHOUT ANY ISSUES OR ADVERSE CONSEQUENCES TO THE PATIENT. ON A UNKNOWN DATE IN (B)(6) 2024 IT WAS DISCOVERED THE SURGICAL SITE HAD DEVELOPED AN INFECTION (COMPLAINT (B)(4)). DURING POST OPERATIVE FOLLOW UP IT WAS ALSO DISCOVERED THE LOCK SCREW AT LEFT C7 AND LEFT T1 WERE DISLODGED. ON (B)(6) 2024 A REVISION SURGERY OCCURRED WHERE THE DISLODGED SCREWS WERE EXPLANTED AND REPLACED AND THE INCISION SITE WAS CLEANSED. THE REVISION WAS COMPLETED WITH NO FURTHER ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 18866604 ↗
• MalfunctionMar 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2023 A PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE FROM C7 TO T9. THE SURGERY WAS COMPLETED WITHOUT ANY ISSUES OR ADVERSE CONSEQUENCES TO THE PATIENT. ON A UNKNOWN DATE IN (B)(6) 2024 IT WAS DISCOVERED THE SURGICAL SITE HAD DEVELOPED AN INFECTION(B)(4). DURING POST OPERATIVE FOLLOW UP IT WAS ALSO DISCOVERED THE LOCK SCREW AT LEFT C7 AND LEFT T1 WERE DISLODGED. ON (B)(6) 2024 A REVISION SURGERY OCCURRED WHERE THE DISLODGED SCREWS WERE EXPLANTED AND REPLACED AND THE INCISION SITE WAS CLEANSED. THE REVISION WAS COMPLETED WITH NO FURTHER ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 18866544 ↗
• MalfunctionNov 17, 2023Migration; Migration

  ON (B)(6) 2023 A PATIENT UNDERWENT A COMBINATION POSTERIOR SPINAL FIXATION AND XTREME LATERAL INTERBODY FUSION PROCEDURE FROM T7 TO L2. THE SURGERY WAS COMPLETED WITHOUT ISSUE. THREE MONTHS LATER DURING A ROUTINE POST OP APPOINTMENT IT WAS REPORTED THE PATIENT WAS EXPERIENCING UNSPECIFIC BACK PAIN. MRIS/RADIOGRAPHS OCCURRED WHICH DISCOVERED THE TWO LOCK SCREW AT THE L2 LEVEL HAD EXPELLED FROM THEIR SEATED TULIP. ON (B)(6) 2023 WE WERE INFORMED A REVISION OCCURRED TO RESEAT AND SECURE THE EXPELLED LOCK SCREW. DURING THE PROCEDURE IT WAS ADDITIONALLY FOUND 4 OTHER SET SCREWS WERE LOOSE AT BOTH L1 LEVELS AS WELL AS THE RIGHT T12 AND T11. DURING THE REVISION ALL LOOSE AND EXPELLED LOCK SCREWS WERE REUSED AND RESECURED WITH TORQUE AND COUNTER TORQUE. THE REVISION WAS COMPLETED WITH NO FURTHER ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: Pain

  MAUDE report 18166237 ↗
• MalfunctionNov 17, 2023Migration; Migration

  NEW OR UPDATED INFORMATION LISTED IN SECTION H10.

  Patient problems: Pain

  MAUDE report 18165629 ↗
• MalfunctionNov 17, 2023Migration; Migration

  NEW OR UPDATED INFORMATION LISTED ON SECTION H10.

  Patient problems: Pain

  MAUDE report 18165559 ↗
• MalfunctionNov 17, 2023Migration; Migration

  NEW OR UPDATED INFORMATION LISTED IN SECTION H10.

  Patient problems: Pain

  MAUDE report 18165394 ↗
• MalfunctionNov 17, 2023Migration; Migration

  ON JULY 19 2023, A PATIENT UNDERWENT A COMBINATION POSTERIOR SPINAL FIXATION AND XTREME LATERAL INTERBODY FUSION PROCEDURE FROM T7 TO L2. THE SURGERY WAS COMPLETED WITHOUT ISSUE. THREE MONTHS LATER DURING A ROUTINE POST OP APPOINTMENT IT WAS REPORTED THE PATIENT WAS EXPERIENCING UNSPECIFIC BACK PAIN. MRIS/RADIOGRAPHS OCCURRED WHICH DISCOVERED THE TWO LOCK SCREW AT THE L2 LEVEL HAD EXPELLED FROM THEIR SEATED TULIP. ON (B)(6) 2023 WE WERE INFORMED A REVISION OCCURRED TO RESEAT AND SECURE THE EXPELLED LOCK SCREW. DURING THE PROCEDURE IT WAS ADDITIONALLY FOUND 4 OTHER SET SCREWS WERE LOOSE AT BOTH L1 LEVELS AS WELL AS THE RIGHT T12 AND T11. DURING THE REVISION ALL LOOSE AND EXPELLED LOCK SCREWS WERE REUSED AND RESECURED WITH TORQUE AND COUNTER TORQUE. THE REVISION WAS COMPLETED WITH NO FURTHER ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: Pain

  MAUDE report 18165316 ↗
• MalfunctionNov 17, 2023Migration; Migration

  ON (B)(6) 2023 A PATIENT UNDERWENT A COMBINATION POSTERIOR SPINAL FIXATION AND EXTREME LATERAL INTERBODY FUSION PROCEDURE FROM T7 TO L2. THE SURGERY WAS COMPLETED WITHOUT ISSUE. THREE MONTHS LATER DURING A ROUTINE POST OP APPOINTMENT IT WAS REPORTED THE PATIENT WAS EXPERIENCING UNSPECIFIC BACK PAIN. MRIS/RADIOGRAPHS OCCURRED WHICH DISCOVERED THE TWO LOCK SCREW AT THE L2 LEVEL HAD EXPELLED FROM THEIR SEATED TULIP. ON (B)(6) 2023 WE WERE INFORMED A REVISION OCCURRED TO RESEAT AND SECURE THE EXPELLED LOCK SCREW. DURING THE PROCEDURE IT WAS ADDITIONALLY FOUND 4 OTHER SET SCREWS WERE LOOSE AT BOTH L1 LEVELS AS WELL AS THE RIGHT T12 AND T11. DURING THE REVISION ALL LOOSE AND EXPELLED LOCK SCREWS WERE REUSED AND RESECURED WITH TORQUE AND COUNTER TORQUE. THE REVISION WAS COMPLETED WITH NO FURTHER ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: Pain

  MAUDE report 18165265 ↗
• MalfunctionJan 18, 2022Migration or Expulsion of Device; Migration; Migration or Expulsion of Device; Migration

  ON (B)(6) 2021 A PATIENT UNDERWENT A TEN LEVEL POSTERIOR FIXATION PROCEDURE. ON (B)(6), 2021 DURING A ROUTINE FOLLOW UP RADIOGRAPHS IDENTIFIED ROD LENGTH DID NOT LOOK THE SAME AS POST OP RADIOGRAPHS AS WELL AS LOSS OF CORRECTION (INCREASED TILT) AT THE BOTTOM RIGHT SET SCREW OF THE CONSTRUCT. (BOTTOM RIGHT SET SCREW) ON (B)(6), 2021 A REVISION PROCEDURE WAS CONDUCTED WHERE THE MOST CAUDAL PEDICLE SCREW ON THE RIGHT SIDE AND LOCK SCREW WERE REPLACED. PATIENT WAS ASYMPTOMATIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13287171 ↗
• MalfunctionDec 6, 2021Migration; Migration

  INFORMATION WAS INITIALLY RECEIVED THAT A REVISION SURGERY WAS PERFORMED TO ADDRESS LOOSENED LOCK SCREWS. SUBSEQUENTLY, AN X-RAY IMAGE WAS PROVIDED, WHICH REVEALED A LOCK SCREW HAD BACKED OUT COMPLETELY AND ALLOWED ITS ASSOCIATED HOOK TO SEPARATE FROM THE ROD AND FIXATION. ALTHOUGH REVISION WAS NECESSARY, THERE WAS NO REPORT OF ANY OTHER ADVERSE PATIENT IMPACT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12938701 ↗
• MalfunctionFeb 24, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2021, IT WAS REPORTED THAT THERE HAS BEEN A METAL NOISE WHEN THE PATIENT SAT IN A CHAIR. CT SCAN SHOWS NO ABNORMALITIES AND SO THERE IS NO REVISION SURGERY PLANNED FOR NOW.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11373308 ↗
• MalfunctionDec 8, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  THE PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE WITH RELINE PRODUCTS ON (B)(6) 2020. ON (B)(6) 2020, A REVISION SURGERY WAS PERFORMED TO REPLACE A LOOSENED LOCK SCREW OF SAI WITH NEW ONE. AT THAT TIME, THE PHYSICIAN NOTICED THAT THE MULTIPLE OTHERS LOCK SCREW HAD BEEN ALSO LOOSE. AS A RESULT, THE PHYSICIAN REPLACED THE 19 LOCK SCREWS WITH NEW ONES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10972279 ↗
• InjuryJan 25, 2019Misassembled; Misassembled

  ON (B)(6) 2018, PATIENT UNDERWENT A POSTERIOR SPINAL FUSION PROCEDURE. IT WAS CONFIRMED THAT SET SCREWS WERE NOT PLACED AT SAI SCREWS AFTER WOUND CLOSURE. AN ADDITIONAL PROCEDURE WAS PERFORMED, AND THE SET SCREWS WERE PLACED.

  Patient problems: Not Applicable

  MAUDE report 8279962 ↗
• InjuryDec 5, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  RECEIVED INFORMATION STATING PATIENT UNDERWENT A REVISION PROCEDURE DUE TO POST-OPERATIVE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8136242 ↗
• MalfunctionOct 10, 2018Break; Break

  ON (B)(6) 2018, PATIENT UNDERWENT A SPINAL FUSION PROCEDURE AT T9-S2 LEVELS USING RELINE AND M5. POST-OPERATIVE RADIOGRAPHS SHOWED A SCREW BACK-OUT AT THE RIGHT SIDE OF S1 LEVEL. A REVISION PROCEDURE IS PLANNED BUT HAS NOT BEEN PERFORMED.

  Patient problems: Failure of Implant

  MAUDE report 7953131 ↗
• MalfunctionAug 15, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  AS PER REPORTER PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2018 DUE TO LOCK SCREW DISASSOCIATIONS. PATIENT WAS EXPERIENCING SORENESS AND A BUMP, NO PATIENT INJURY WAS REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 7786694 ↗
• MalfunctionJan 29, 2018Unintended Movement; Unintended Movement

  A PATIENT UNDERWENT POSTERIOR SPINAL FUSION AT L4-5 LEVELS USING MEDTRONIC LEGACY 5.5 (DATE UNKNOWN). ON (B)(6) 2017, STRYKER PEDICLE SCREWS WERE PLACED AT T11-12 LEVELS, HOOKS WERE PLACED AT T10 LEVEL AND RELINE-O CONNECTORS WERE PLACED AT L4/5 LEVELS, STRYKER 6.0 MM COCR RODS WERE PLACED. REPORTEDLY, L1-L3 LEVELS WERE SKIPPED DUE TO SPINAL CARIES. ON (B)(6) 2018, IT WAS CONFIRMED THAT ONE SIDE OF THE ROD WAS CRANIALLY DISPLACED AND SEPARATED FROM THE CONNECTOR. A REVISION PROCEDURE IS PLANNED ON (B)(6) 2018, TO REPLACE THE CONNECTOR WITH STRYKER'S CONNECTOR. NO PATIENT INJURY HAS BEEN REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 7224865 ↗