The Tether™ 211H6030Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00880304864931), received between May 13, 2021 and Nov 7, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Unintended Movement” (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. How this data works · Data updated Oct 13, 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.

• InjuryNov 7, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO RELEASE A TETHER CORD BETWEEN T11 AND L2 BECAUSE THE PATIENT HAS 16 DEGREES OF OVERCORRECTION. THE OVERCORRECTION WAS DISCOVERED DURING A 3 YEAR POST-OPERATIVE FOLLOW-UP VISIT. DURING THE REVISION, THE CORD WAS FOUND BROKEN BETWEEN T11 AND T12. THE CORD BETWEEN T11 AND L2 AND THE SCREWS BETWEEN T11 AND L1 WERE REMOVED DURING THE PROCEDURE. THIS IS REPORT THREE OF FOUR FOR THIS EVENT.

  Patient problems: Spinal Column Injury

  MAUDE report 20634816 ↗
• InjuryNov 7, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO RELEASE A TETHER CORD BETWEEN T11 AND L2 BECAUSE THE PATIENT HAS 16 DEGREES OF OVERCORRECTION. THE OVERCORRECTION WAS DISCOVERED DURING A 3 YEAR POST-OPERATIVE FOLLOW-UP VISIT. DURING THE REVISION, THE CORD WAS FOUND BROKEN BETWEEN T11 AND T12. THE CORD BETWEEN T11 AND L2 AND THE SCREWS BETWEEN T11 AND L1 WERE REMOVED DURING THE PROCEDURE. THIS IS REPORT TWO OF FOUR FOR THIS EVENT.

  Patient problems: Spinal Column Injury

  MAUDE report 20633425 ↗
• InjuryMay 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOUR MONTHS POST-OP, THE PATIENT'S SCOLIOSIS CURVE CHANGED FROM 51 DEGREES PRE-OP TO 19 DEGREES POST-OP IN THE LUMBAR REGION, FROM 68 DEGREES PRE-OP TO 50 DEGREES POST-OP IN THE THORACIC REGION, BUT DEVELOPED A TRUNK ROTATION IN THE THORACIC REGION THAT MEASURES 30 DEGREES ON THE INCLINOMETER REDUCES TO 20 DEGRESS IN A PRONE POSITION. THE DECISION WAS MADE TO REMOVE THE CONSTRUCT AND FUSE THE ASSOCIATED LEVELS (T5-L4) TOGETHER. THIS IS REPORT TWENTY THREE OF THIRTY NINE FOR THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11817405 ↗
• InjuryMay 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOUR MONTHS POST-OP, THE PATIENT'S SCOLIOSIS CURVE CHANGED FROM 51 DEGREES PRE-OP TO 19 DEGREES POST-OP IN THE LUMBAR REGION, FROM 68 DEGREES PRE-OP TO 50 DEGREES POST-OP IN THE THORACIC REGION, BUT DEVELOPED A TRUNK ROTATION IN THE THORACIC REGION THAT MEASURES 30 DEGREES ON THE INCLINOMETER REDUCES TO 20 DEGRESS IN A PRONE POSITION. THE DECISION WAS MADE TO REMOVE THE CONSTRUCT AND FUSE THE ASSOCIATED LEVELS (T5-L4) TOGETHER. THIS IS REPORT TWENTY FOUR OF THIRTY NINE FOR THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11817401 ↗