ReLine 16026545Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00887517556639), received between Oct 15, 2018 and May 21, 2026 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2026Unintended Movement

  IT WAS REPORTED THAT A PRIMARY SURGERY TOOK PLACE ON (B)(6) 2026; XLIF AND SPINAL FIXATION AT L2/3/4/5. A SECOND SURGERY WAS PERFORMED BECAUSE THE SCREW HAD DISLODGED. WHEN THE SURGEON ATTEMPTED TO REMOVE THE DISLODGED SCREW, THE SCREW HEAD HAD DETACHED FROM THE SHANK. THE SHANK WAS REMOVED FROM THE BONE, AND THE HEAD AND OTHER PART WERE REMOVED WITH FORCEPS. THERE WAS NO OTHER ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25241858 ↗
• MalfunctionAug 27, 2024Break; Break

  ON (B)(6) 2020, A PATIENT UNDERWENT A POSTERIOR SPINAL FIXATION PROCEDURE FROM L2 TO L5. ON (B)(6) 2024 THE PATIENT PRESENTED WITH BACK PAIN. EVALUATION OF THE PATIENT IDENTIFIED THE LEFT L5 PEDICLE SCREW HAD BROKEN. NO INDICATION OF A REVISION SURGERY BEING CONDUCTED OR PLANNED HAS BEEN PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 20077811 ↗
• InjuryJan 12, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED IN A CLINICAL STUDY THAT A PATIENT UNDERWENT AN EXTREME LATERAL INTERBODY FUSION AT L3/5 ON (B)(6), 2022. ON (B)(6), 2022 A CT REVEALED THERE WAS A LEFT L4 PEDICLE BREACH CORRESPONDING WITH LEFT LEG PAIN. TREATMENT WAS REMOVAL OF LEFT-SIDED SCREWS ON (B)(6), 2023.

  Patient problems: Pain

  MAUDE report 18507506 ↗
• InjuryOct 14, 2022Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL POSTERIOR FIXATION PROCEDURE FROM T10 TO L1. SUBSEQUENTLY, IT WAS IDENTIFIED THROUGH POSTOPERATIVE CT IMAGING THAT THE RIGHT PEDICLE SCREW AT THE T12 LEVEL WAS MALPOSITIONED MEDIALLY. THE PATIENT DID NOT REPORT EXPERIENCING ANY PAIN OR OTHER ADVERSE SYMPTOMS AS A RESULT OF THE PLACEMENT. APPROXIMATELY SEVEN (7) DAYS LATER, THE PATIENT UNDERWENT A REVISION PROCEDURE TO REMOVE THE MALPOSITIONED SCREW. NO NEW SCREW WAS IMPLANTED INTO THE RIGHT T12 LOCATION. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15611115 ↗
• MalfunctionAug 12, 2021Fracture; Fracture

  ON (B)(6) 2020 A FEMALE PATIENT, OF LARGER SIZE, UNDERWENT A TRANSFORAMINAL LUMBAR INTERBODY FUSION PROCEDURE FROM THE L5-S1 LEVELS. ON A UNKNOWN DATE IT WAS DISCOVERED THE PATIENT EXPERIENCED BILATERAL FRACTURES OF THE IMPLANTS SCREWS AT THE S1 LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12314000 ↗
• InjuryMar 11, 2021Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A SPINAL PROCEDURE TO ADDRESS A RUPTURE FRACTURE. AFTER COLLECTING AUTOLOGOUS BONE FROM THE ILIUM A PEDICLE SCREW WAS PERCUTANEOUSLY INSERTED INTO L2. SUBSEQUENTLY THE PATIENT'S BLOOD PRESSURE DROPPED, AND CARDIOPULMONARY ARREST OCCURRED. THERE WAS NO ABNORMALITY IN THE IMAGE AT THE TIME WHEN THE PEDICLE SCREW WAS INSERTED. THE PEDICLE SCREW WAS IMMEDIATELY REMOVED, THE INCISION WAS CLOSED WITH SURGICAL STAPLES, AND THE PATIENT WAS RETURNED TO THE SUPINE POSITION FOR CARDIAC MASSAGE. THE OPERATION WAS DISCONTINUED AND IS NOW RESCHEDULED ON ANOTHER DAY.

  Patient problems: Cardiac Arrest

  MAUDE report 11465580 ↗
• MalfunctionDec 4, 2020Fracture; Fracture

  ON (B)(6) 2017 A MINIMALLY INVASIVE LUMBAR INTERBODY FUSION WAS PERFORMED AT L3-S1. AN X-RAY ON (B)(6) 2018 REVEALED BROKEN RIGHT PEDICLE SCREW AT S1. THE PATIENT REPORTEDLY HAS BACK PAIN AND IS REQUIRED TO UNDERGO A REVISION SURGERY TO ATTEMPT TO ALLEVIATE THE PAIN.

  Patient problems: Pain

  MAUDE report 10944197 ↗
• MalfunctionSep 25, 2020Separation Problem; Separation Problem

  ON (B)(6) 2020, A PATIENT UNDERWENT SPINAL PROCEDURE. ON (B)(6) 2020, RADIOGRAPHS INDICATE THE MASS REDUCTION SCREW DID NOT BREAK OFF CORRECTLY. AS PER REPORTER, IT HAS NOT BEEN DECIDED IF PATIENT WILL UNDERGO A REVISION PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10587130 ↗
• MalfunctionOct 15, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6) 2018 PATIENT UNDERWENT AN EXTREME LATERAL INTERBODY FUSION PROCEDURE WITH NO REPORTED ISSUES. ON (B)(6) 2018 PATIENT UNDERWENT A REVISION PROCEDURE DUE TO HARDWARE MALPOSITION. NO OTHER INFORMATION PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 7965968 ↗