TRANSLACE™ Spinal Tethering System 8205300 (UDI 00763000108380)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000108380), received between Apr 19, 2019 and Apr 20, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 20, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A TRANSLACE CONNECTOR. IT WAS REPORTED THAT THE IMPLANT BECAME LOOSE OVER TIME AFTER THE INITIAL OPERATION. SO IT WAS EXPLANTED. PRE-OPERATIVE DIAGNOSIS OF THIS SURGERY WAS LOOSENING OF THE IMPLANT DUE TO DETERIORATION OVER TIME. NO ADVERSE EVENT OCCURRED TO PATIENT. THERE WERE NO FURTHER COMPLICATIONS THAT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16776187 ↗
• InjuryApr 19, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR LUMBAR FUSION AND FIXATION AT T6-L3 DUE TO KYPHOSIS. AFTER APPROXIMATELY ONE WEEK POST-OP, PATIENT HAD FEVER. WHEN EVALUATION WAS PERFORMED, INFECTION WAS FOUND. HENCE, A REVISION SURGERY WAS PERFORMED FOR THE REMOVAL OF ALL IMPLANTS ON (B)(6) 2019. DURING THE REVISION SURGERY, IT WAS FOUND THAT THE CONNECTORS WERE VERY TIGHT AND IT WAS DIFFICULT TO REMOVE THE CONNECTORS. THE REMOVAL WAS CARRIED OUT BY GRASPING THE ROD WITH A ROD GRIPPER. NO TENSIONER WAS USED. THE SEVERITY OF THE INFECTION WAS DETERMINED TO BE NOT SERIOUS. ALLEGEDLY, THE PATIENT HAS STILL NOT RECOVERED. THE RELATEDNESS OF THE INFECTION WITH THE IMPLANTS OR SURGICAL PROCEDURE COULD NOT BE DETERMINED.

  Patient problems: Fever; Unspecified Infection

  MAUDE report 8531075 ↗