ReLine 12360500Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00887517507648), received between Feb 25, 2020 and Dec 21, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 21, 2022Fracture; Fracture

  ON (B)(6) 2020 A PATIENT UNDERWENT A SPINAL PROCEDURE AT L1/S1. IN (B)(6) 2022 ON AN UNKNOWN DATE THE PATIENT REPORTED BACK PAIN AND ROD FRACTURES WERE FOUND ON BOTH SIDES OF L4/5. BONE FUSION WAS ACHIEVED AT L4. ON (B)(6) 2022 A REVISION WAS SCHEDULED AND NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 16030022 ↗
• MalfunctionDec 21, 2022Fracture; Fracture

  ON (B)(6) 2020 A PATIENT UNDERWENT A SPINAL PROCEDURE AT L1/S1. IN NOVEMBER 2022 ON AN UNKNOWN DATE THE PATIENT REPORTED BACK PAIN AND ROD FRACTURES WERE FOUND ON BOTH SIDES OF L4/5. BONE FUSION WAS ACHIEVED AT L4. ON (B)(6) 2022 A REVISION WAS SCHEDULED AND NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 16030018 ↗
• MalfunctionMar 23, 2022Fracture; Fracture

  ON (B)(6) 2020 A PATIENT UNDERWENT A REVISION PROCEDURE TO EXTEND A CONSTRUCT TO T5, FROM AN EXISTING T9-ILIAC CONSTRUCT, AS A RESULT OF A VERTEBRAL FRACTURE THAT OCCURRED AT T5 DUE TO A CONTINUED DECLINE IN PATIENT PATHOLOGY. A SUBSEQUENT REVISION OCCURRED ON (B)(6) 2020 WHERE THE CONSTRUCT WAS EXTENDED AGAIN TO T2 DUE TO ANOTHER VERTEBRAL FRACTURE OCCURRING AT T5 AS A CONSEQUENCE OF A CONTINUED DECLINE IN PATIENT PATHOLOGY. ON (B)(6) 2022 WHILE SHOVELING SNOW THE PATIENT HEARD A NOISE FROM THEIR BACK SO THEY CONTACTED THEIR PHYSICIAN AND IT WAS DISCOVERED THAT THE PATIENT HAD EXPERIENCED A ROD FRACTURE BETWEEN T8-T10. BONE FUSION WAS COMPLETE AND THE PATIENT WAS EXPERIENCING NO PAIN. ON (B)(6) 2022 A REVISION OCCURRED WHERE THE DAMAGED DEVICE WAS EXPLANTED AND DISPOSED OF. NO OTHER DETAILS OF THE REVISION WERE AVAILABLE AND PATIENT IS REPORTED TO BE DOING WELL POST REVISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13861706 ↗
• MalfunctionAug 19, 2021Misassembled During Installation; Misassembled During Installation

  ON (B)(6) 2021 A PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE FROM T10-L5. IN JULY ON A UNKNOWN DATE DURING A ROUTINE POST OP FOLLOW UP A RADIOGRAPH REVEALED THAT THE THAT THE ROD WAS INSTALLED IN REVERSE AGAINST THE CURVATURE. ACCORDING TO INFORMATION RECEIVED, THE BENT ROD WAS ALMOST STRAIGHT AND SO THE SCREWS WERE NOT LOOSE AND THE PATIENT HAD NO PAIN. ON (B)(6) 2021 A REVISION OCCURRED WHERE THE DEVICE WAS REPLACED WITH A NEW ROD. THE REVISION OPERATION WAS SUCCESSFULLY COMPLETED AND THE PATIENT IS RECOVERING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12345295 ↗
• MalfunctionApr 27, 2021Fracture; Fracture

  ON (B)(6) 2019 A PATIENT UNDERWENT AN EXTREME LATERAL INTERBODY FUSION AND A POSTERIOR FIXATION PROCEDURE AT T10/S2. ON AN UNKNOWN DATE AN IMPLANTED ROD FRACTURED AT L5/S. BONE FUSION WAS OBSERVED THEREFORE NO REVISION SURGERY IS PLANNED PER THE SURGEON'S PREROGATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11732672 ↗
• MalfunctionApr 28, 2020Fracture; Fracture

  PATIENT WAS REPORTED TO HAVE BEEN EXPERIENCING PAIN AND FRACTURED RODS WERE DISCOVERED. ON (B)(6) 2020, PATIENT UNDERWENT A REVISION PROCEDURE AS RODS BROKE AT LEFT L2 AND RIGHT L3 LEVELS.

  Patient problems: Cancer; Failure of Implant

  MAUDE report 10007634 ↗
• MalfunctionFeb 25, 2020Fracture; Fracture

  IN (B)(6) 2018, PATIENT UNDERWENT A SPINAL PROCEDURE AT T11-L4 AND L1- L2 WERE SKIPPED. AN X-RAY REVEALED THAT THE RIGHT SIDE ROD BROKE AT L1-L2 LEVELS. PATIENT UNDERWENT A REMOVAL PROCEDURE ON (B)(6) 2020, DUE TO COMPLETED BONE FUSION. NO PATIENT INJURY REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 9751007 ↗