TLX 5902931P2Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887517958419), received between Jan 14, 2025 and Mar 14, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS IDENTIFIED DURING A REVIEW OF THE LUMBAR INTERBODY STUDY, THE REPORT IDENTIFIED THAT ON (B)(6) 2024 TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L5-S1 WITH BILATERAL POSTERIOR FIXATION L5-S1. ON (B)(6) 2024 PULMONARY EMBOLISM PRESENTED TO THE ED ON (B)(6)2024 WITH ACUTE ONSET CHEST PAIN THAT RADIATES INTO THE BACK PAIN WAS SO SEVERE PATIENT TOOK AN OXYCODONE PRIOR TO ED ARRIVAL. ON EXAM IN ED, AFEBRILE, TACHYPNEA, SATING 93% RA AND CT SHOWED SMALL ACUTE PE AND RIGHT UPPER LOBE, RIGHT LOWER LOBE SHOWS GROUND-GLASS CHANGES WITH ATELECTASIS CONCERN FOR POSSIBLE PULMONARY INFARCT. PATIENT WAS ADMITTED ON HEPARIN DRIP. ALSO CONCERN FOR COMMUNITY ACQUIRED PNEUMONIA BASED ON CT AND ELEVATED WBC. STABLE ON DISCHARGE ON (B)(6) 2024 ON (B)(6) 2025, PATIENT HAS BEEN EXPERIENCING SIGNIFICANTLY WORSENING LLE PAIN, WORSE SINCE SURGERY. REPORTS A LIMP AND DIFFICULTY AMBULATING WITH HIS LLE, REPORTING THIS IS NEW SINCE SURGERY. ALSO DOES REPORT EPISODES OF HIS LEFT LEG GIVING OUT ON HIM AND LLE WEAKNESS. PATIENT REPORTS SIGNIFICANT PAIN BEHIND LEFT KNEE AND OUTSIDE LEFT KNEE AND LEG TURNING INTO NUMBNESS ON THE OUTER PORTION OF HIS FOOT AND TOES. HE REPORTS HIS TOES ARE CURLED.

  Patient problems: Ambulation or Postural Difficulties; Limb Pain; Muscle Weakness/Atrophy; Numbness

  MAUDE report 21609912 ↗
• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS IDENTIFIED DURING A REVIEW OF THE LUMBAR INTERBODY STUDY, THE REPORT IDENTIFIED THAT ON (B)(6) 2024 TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L5-S1 WITH BILATERAL POSTERIOR FIXATION L5-S1. ON (B)(6) 2024 PULMONARY EMBOLISM PRESENTED TO THE ED ON (B)(6) 2024 WITH ACUTE ONSET CHEST PAIN THAT RADIATES INTO THE BACK PAIN WAS SO SEVERE PATIENT TOOK AN OXYCODONE PRIOR TO ED ARRIVAL. ON EXAM IN ED, AFEBRILE, TACHYPNEA, SATING 93% RA AND CT SHOWED SMALL ACUTE PE AND RIGHT UPPER LOBE, RIGHT LOWER LOBE SHOWS GROUND-GLASS CHANGES WITH ATELECTASIS CONCERN FOR POSSIBLE PULMONARY INFARCT. PATIENT WAS ADMITTED ON HEPARIN DRIP. ALSO CONCERN FOR COMMUNITY ACQUIRED PNEUMONIA BASED ON CT AND ELEVATED WBC. STABLE ON DISCHARGE ON (B)(6) 2024

  Patient problems: Back pain; Chest Pain; Pneumonia; Pulmonary Embolism; Tachycardia

  MAUDE report 21578331 ↗
• MalfunctionJan 14, 2025Migration; Migration

  THE EVENT WAS IDENTIFIED DURING A REVIEW OF THE PMCF LUMBAR INTERBODY STUDY, THE REPORT IDENTIFIED THAT ON (B)(6) 2022 A PATIENT UNDERWENT A TWO LEVEL TRANSFORAMINAL LUMBAR INTERBODY FUSION PROCEDURE AT L4/5 AND L5/S1. ON (B)(6) 2022 FOLLOW UP RADIOGRAPHS NOTED SUBSIDENCE OF BOTH INTERBODY'S (L4-5, L5-S1). NO REVISION OR TREATMENT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21149470 ↗