The Tether™ 204H0300Recalls & reported problems
Zimmer Biomet Inc · 300MM VBT CORD · Class N
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Zimmer Biomet Tether 300MM vertebral body tethering cord is used in spine surgery to correct scoliosis curves. The 28 reports describe the tether cord breaking or fracturing, sometimes at the curve's apex, letting the curve return and requiring revision surgery to remove and replace the cord and screws; a few mention overcorrection that had to be loosened. All 28 reports describe injuries, with no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 29
- Deaths reported
- 0
- Injuries reported
- 29
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00880304865068), received between May 13, 2021 and Sep 11, 2026 — classified as 29 injuries.
The most frequently reported specific device problem is “Unintended Movement” (11 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.
Reports received per month
Most reported problems
Device problems
- Unintended Movement11
- Break10
- Fracture7
- Adverse Event Without Identified Device or Use Problem2
- Mechanical Problem1
- Retraction Problem1
Patient problems
- Spinal Column Injury16
- Insufficient Information4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Failure of Implant3
- No Clinical Signs, Symptoms or Conditions3
- Deformity/ Disfigurement2
- Pain2
- Scar Tissue1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
InjurySep 11, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743141 ↗InjuryAug 5, 2026Fracture
It was reported that a revision surgery had been performed 18 months post-op to address a Tether cord that had fractured at T9-10. Removal of the cord from T4-T12 was completed, the Tether was locked at T5 and screws were replaced at T6, T7, and T11. The cord was then re-tensioned T5-T12.
Patient problems: Insufficient Information
MAUDE report 50148144 ↗InjuryAug 15, 2025Fracture; Fracture
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REPLACE A BROKEN TETHER CORD. THE BROKEN CORD WAS REMOVED AND REPLACED WITH A NEW ONE ALONG WITH NEW SET SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22816781 ↗InjuryJun 25, 2025Fracture; Fracture
IT WAS REPORTED THAT A TETHER CORD FRACTURED AT T11-12 AND T12-L1 (THE CURVE'S APEX), RESULTING IN REVISION AND REPLACEMENT WITH A NEW CORD. THE INITIAL CONSTRUCT RAN FROM T6-L3 FOR A RIGHT-SIDED CURVE. THE CURVE HAD REGRESSED TO AROUND 50 DEGREES AS A RESULT OF THE FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22328664 ↗InjuryMay 6, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT A TETHER REVISION SURGERY WAS PERFORMED TO ADDRESS AN OVERCORRECTION IDENTIFIED DURING A FOLLOW-UP APPOINTMENT. THE INITIAL SURGERY HAD BEEN TWO YEARS PRIOR. THE CORD AND 8 SCREWS WERE SUCCESSFULLY REMOVED IN ORDER TO RESTORE CURVATURE. THIS IS REPORT ONE OF NINE FOR THIS EVENT.
Patient problems: Spinal Column Injury
MAUDE report 21969357 ↗InjuryOct 3, 2024Break; Unintended Movement; Break; Unintended Movement
IT WAS REPORTED THAT A REVISION SURGERY WILL BE PERFORMED TO RELEASE A TETHER CORD BETWEEN T11 AND L2 BECAUSE THE PATIENT HAS 16 DEGREES OF OVER CORRECTION. THE OVER CORRECTION WAS DISCOVERED DURING A 3 YEAR POST-OPERATIVE FOLLOW-UP VISIT.
Patient problems: Spinal Column Injury
MAUDE report 20363537 ↗InjuryOct 2, 2024Fracture; Unintended Movement; Fracture; Unintended Movement
IT WAS REPORTED THAT A TETHER REMOVAL SURGERY WAS PERFORMED APPROXIMATELY 14 MONTHS POST-OPERATIVELY DUE TO PATIENT'S WORSENING LEFT LUMBAR SCOLIOSIS AND RIGHT THORACIC CURVE PATTERN.
Patient problems: Spinal Column Injury
MAUDE report 20354712 ↗InjurySep 13, 2024Break; Break
IT WAS REPORTED THAT A TETHER REVISION SURGERY WAS PERFORMED TO ADDRESS A POST-OPERATIVE CORD BREAKAGE. FURTHER INFORMATION REGARDING PATIENT IMPACT IS UNAVAILABLE AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 20218479 ↗InjurySep 5, 2024Break; Break
IT WAS REPORTED THAT A TETHER REVISION SURGERY WAS PERFORMED TO ADDRESS A POST-OPERATIVE CORD BREAKAGE. APPROXIMATELY 6 MONTHS POST-OPERATIVELY, THE PATIENT RETURNED FOR CONSULTATIONS FOR PAIN IN THE THORACOLUMNAR AREA. AN X-RAY WAS THEN PERFORMED THAT REVEALED A CORD RUPTURE AT THE T12 SCREW WITH LOSS OF CORRECTION BETWEEN T11 AND L1. THE CONSEQUENCES OF THIS RUPTURE INCLUDE PAIN, LOSS OF CORRECTION, AND A REVISION SURGERY THAT INVOLVED EXPLANTING THE RUPTURED CORD AND RE-IMPLANTING A NEW ONE BETWEEN T7 AND L3.
Patient problems: Insufficient Information; Pain; Spinal Column Injury
MAUDE report 20152876 ↗InjuryJul 19, 2024Unintended Movement; Unintended Movement
IT WAS REPORTED THAT A TETHER REVISION SURGERY WAS PERFORMED DUE TO OVERCORRECTION; THE CORD WAS REMOVED FROM LEVELS T10-L2. THE PATIENT EXPERIENCED OVERCORRECTION OF 16 DEGREES FOR THE FIRST TIME APPROXIMATELY 6 MONTHS POST-OP AND THE DECISION WAS MADE TO MONITOR UNTIL THE NEXT FOLLOW-UP VISIT WAS COMPLETE. THE FOLLOW-UP VISIT APPROXIMATELY 14 MONTHS LATER SHOWED PROGRESSION OF OVERCORRECTION TO 21 DEGREES. THEN THE DECISION WAS MADE TO PERFORM THE REVISION.
Patient problems: Spinal Column Injury
MAUDE report 19785184 ↗InjuryJul 16, 2024Break; Break
IT WAS REPORTED THAT A TETHER REVISION SURGERY WAS PERFORMED TO ADDRESS CORD RUPTURE AND CURVE REGRESSION. A POSTERIOR SPINAL FIXATION CONSTRUCT WAS ADDED DURING THE REVISION.
Patient problems: Spinal Column Injury
MAUDE report 19755259 ↗InjuryJul 16, 2024Unintended Movement; Unintended Movement
IT WAS REPORTED THAT A TETHER REVISION SURGERY WAS PERFORMED TO ADDRESS THE COSMETICS OF A HYPERTROPHIC SCAR AND FOR PROGRESSION OF THE CURVE. A POSTERIOR SPINAL FIXATION CONSTRUCT WAS ADDED DURING THE REVISION.
Patient problems: Scar Tissue; Spinal Column Injury
MAUDE report 19754917 ↗InjuryJul 16, 2024Break; Break
IT WAS REPORTED THAT A TETHER REVISION SURGERY WAS PERFORMED TO ADDRESS CORD RUPTURE. A POSTERIOR SPINAL FIXATION CONSTRUCT WAS ADDED DURING THE REVISION.
Patient problems: Failure of Implant
MAUDE report 19752409 ↗InjuryJul 16, 2024Unintended Movement; Unintended Movement
IT WAS REPORTED THAT A TETHER RELEASE SURGERY WAS PERFORMED TO ADDRESS OVERCORRECTION.
Patient problems: Spinal Column Injury
MAUDE report 19752309 ↗InjuryJul 16, 2024Unintended Movement; Unintended Movement
IT WAS REPORTED THAT A REVISION/REPLACEMENT TETHER SURGERY WAS PERFORMED TO ADDRESS OVERCORRECTION.
Patient problems: Spinal Column Injury
MAUDE report 19752235 ↗InjuryJul 16, 2024Unintended Movement; Unintended Movement
IT WAS REPORTED THAT A TETHER REVISION SURGERY WAS PERFORMED TO ADDRESS COSMETIC APPEARANCE AND PROGRESSION OF THE CURVE. A POSTERIOR SPINAL FIXATION CONSTRUCT WAS ADDED DURING THE REVISION.
Patient problems: Spinal Column Injury
MAUDE report 19752123 ↗InjuryJul 16, 2024Break; Break
IT WAS REPORTED THAT A TETHER REVISION SURGERY WAS PERFORMED TO ADDRESS CORD RUPTURE AND CURVE REGRESSION. A POSTERIOR SPINAL FIXATION CONSTRUCT WAS ADDED DURING THE REVISION.
Patient problems: Spinal Column Injury
MAUDE report 19752037 ↗InjuryJul 16, 2024Unintended Movement; Unintended Movement
IT WAS REPORTED THAT A TETHER RELEASE REVISION SURGERY WAS PERFORMED TO ADDRESS OVERCORRECTION.
Patient problems: Spinal Column Injury
MAUDE report 19751971 ↗InjuryJul 16, 2024Break; Break
IT WAS REPORTED THAT A TETHER REVISION SURGERY WAS PERFORMED TO ADDRESS POSSIBLE CORD RUPTURE AND CURVE REGRESSION.
Patient problems: Spinal Column Injury
MAUDE report 19751834 ↗InjuryJul 16, 2024Unintended Movement; Unintended Movement
IT WAS REPORTED THAT A TETHER RELEASE REVISION SURGERY WAS PERFORMED TO ADDRESS OVERCORRECTION.
Patient problems: Spinal Column Injury
MAUDE report 19751677 ↗InjuryJul 16, 2024Break; Break
IT WAS REPORTED THAT A TETHER REVISION SURGERY WAS PERFORMED TO ADDRESS CORD RUPTURE AND PROGRESSION OF THE CURVE. A POSTERIOR SPINAL FIXATION CONSTRUCT WAS ADDED DURING THE REVISION.
Patient problems: Spinal Column Injury
MAUDE report 19750961 ↗InjuryMar 29, 2024Break; Unintended Movement; Break; Unintended Movement
IT WAS REPORTED REPORTED A REVISION SURGERY WAS PERFORMED TO ADDRESS CURVE PROGRESSION AND SUSPECTED TETHER CORD BREAKAGE. A POSTERIOR SCREW CONSTRUCT WAS ADDED DURING THE REVISION WITHOUT REMOVING THE TETHER CONSTRUCT.THIS IS REPORT ONE OF FIVE FOR THIS EVENT.
Patient problems: Spinal Column Injury
MAUDE report 19003520 ↗InjuryJan 26, 2024Unintended Movement; Unintended Movement
IT WAS REPORTED THAT A TETHER PATIENT HAD OVERCORRECTION OF 11 DEGREES POST-OPERATIVELY. THE SURGEON BELIEVES THE OVERCORRECTION WAS CAUSED BY THE MOST PROXIMAL SCREWS IN THE CONSTRUCT; THE PROXIMAL CURVE WAS 30 DEGREES. A REVISION SURGERY WAS PERFORMED TO REMOVE THE TWO SETSCREWS FROM T5-6 AND RELEASE THE CORD BETWEEN T6-7 TO PREVENT FURTHER OVERCORRECTION. THIS IS REPORT ONE OF THREE FOR THIS EVENT.
Patient problems: Deformity/ Disfigurement; Failure of Implant
MAUDE report 18591778 ↗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 ONE OF FOUR FOR THIS EVENT.
Patient problems: Deformity/ Disfigurement
MAUDE report 17939944 ↗InjuryNov 19, 2022Fracture; Fracture
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REPLACE A TETHER CORD THAT BROKE IN TWO PLACES POST-OPERATIVELY AFTER THE PATIENT WENT HORSEBACK RIDING.
Patient problems: Failure of Implant
MAUDE report 15831053 ↗
Other Vertebral Body Tethering System devices
- The Tether™ 203H0012Zimmer Biomet Inc · Vertebral Body Tethering System6 reports
- The Tether™ 211H6032Zimmer Biomet Inc · Vertebral Body Tethering System6 reports
- The Tether™ 211H6030Zimmer Biomet Inc · Vertebral Body Tethering System4 reports
- The Tether™ 211H6035Zimmer Biomet Inc · Vertebral Body Tethering System3 reports
- The Tether™ 211H7040Zimmer Biomet Inc · Vertebral Body Tethering System2 reports
- The Tether™ 211H6040Zimmer Biomet Inc · Vertebral Body Tethering System2 reports
- The Tether™ 211H7035Zimmer Biomet Inc · Vertebral Body Tethering System2 reports
- The Tether™ 211H7037Zimmer Biomet Inc · Vertebral Body Tethering System2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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