The Tether™ 211H6035Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00880304864955), received between May 13, 2021 and May 13, 2021 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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 THIRTY ONE OF THIRTY NINE FOR THIS EVENT.

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

  MAUDE report 11817434 ↗
• 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 NINE OF THIRTY NINE FOR THIS EVENT.

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

  MAUDE report 11817429 ↗
• 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 THIRTY OF THIRTY NINE FOR THIS EVENT.

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

  MAUDE report 11817423 ↗