The Tether™ 211H7037Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304865273), received between Jan 24, 2022 and Jan 24, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 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.

• InjuryJan 24, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED A REVISION SURGERY WAS PERFORMED BECAUSE THE SURGEON BELIEVED THE TETHER CORD HAD BROKEN POST-OPERATIVELY. HOWEVER, DURING THE REVISION, THE CORD WAS FOUND TO BE INTACT, BUT SOME OF THE SET SCREWS DID NOT APPEAR TO BE LOCKED AND WERE LOOSE DURING REMOVAL, ESPECIALLY AT L3. THE CORD AND SET SCREWS WERE REMOVED AND REPLACED. THIS IS REPORT FIVE OF SEVEN FOR THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 13334447 ↗
• InjuryJan 24, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED A REVISION SURGERY WAS PERFORMED BECAUSE THE SURGEON BELIEVED THE TETHER CORD HAD BROKEN POST-OPERATIVELY. HOWEVER, DURING THE REVISION, THE CORD WAS FOUND TO BE INTACT, BUT SOME OF THE SET SCREWS DID NOT APPEAR TO BE LOCKED AND WERE LOOSE DURING REMOVAL, ESPECIALLY AT L3. THE CORD AND SET SCREWS WERE REMOVED AND REPLACED. THIS IS REPORT FOUR OF SEVEN FOR THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 13334443 ↗