The Tether™ 211H6025Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304864917), received between Oct 16, 2023 and Oct 16, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Mechanical Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 16, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO ADDRESS OVERCORRECTION OF A TETHER CONSTRUCT. THE SET SCREWS WERE REMOVED FROM T5-T6 AND THE CORD WAS REMOVED FROM T5-T7. AN OVERCORRECTION WAS ORIGINALLY MEASURED AT 10 DEGREES DURING THE SUBJECT'S 1 YEAR VISIT AND WAS MONITORED UNTIL THE NEXT VISIT. AT THE NEXT VISIT APPROXIMATELY 10 WEEKS LATER, THE MISALIGNMENT WAS RE-EVALUATED AND CHANGED TO REFLECT THE CONTINUING OVERCORRECTION, NOW AT 16 DEGREES NEAR THE MOST PROXIMAL END OF THE CONSTRUCT. THIS IS REPORT TWO OF FOUR FOR THIS EVENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17939969 ↗