Dynesys® 01.03711.200Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024482258), received between Sep 14, 2020 and Mar 18, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 18, 2021Fracture; Mechanical Jam; Fracture; Mechanical Jam

  NO CHANGE TO PREVIOUSLY REPORTED EVENT.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11513709 ↗
• InjuryOct 23, 2020Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT WAS IMPLANTED WITH DYNESYS, STABILIZING CORD. DURING OBSERVATION IN THE CLINIC, IT WAS NOTICED THAT THERE SHOULD BE MORE SLACK IN THE CABLE. HENCE THE PATIENT UNDERWENT REVISION SURGERY WHEREIN THE IMPLANT WAS REMOVED AS INDIVIDUAL PIECES. OFF LABEL APPLICATION OF DYNESYS WITHOUT SPACER UNILATERAL PEDICLE PLACEMENT T12/L4.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10725159 ↗
• InjuryOct 7, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  NO CHANGE TO PREVIOUSLY REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10640621 ↗
• InjurySep 14, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT REVISION SURGERY DUE TO NON GROWTH AND CORRECTION OF SPINE AS EXPECTED. THE INITIAL SURGERY INVOLVED POST SPINE IN THE PEDICLE S. LEFT SIDE T10/L4. RIGHT SIDE L4/5. WHICH WERE EXTRACTED & CONVERTED TO A FUSION. THE TETHER WAS NOT PROVIDING THE CORRECTION THAT WAS EXPECTED SINCE THE TENSION APPLIED DIDN¿T PERMIT THE GROWTH SPURT FOR THE PATIENT.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 10526644 ↗