The TetherRecalls & reported problems across all models

We found 11 models of The Tether by Zimmer Biomet Inc in the FDA's device registry (GUDID). Together they are named in 93 adverse event reports in the FDA's MAUDE database, received between Apr 20, 2021 and Sep 11, 2026 — classified as 65 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Fracture” (31 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported The Tether problems

The Tether models

11 models, most reported first. Each model has its own page with its reports, recalls and device details.

• The Tether™ 230H4001

  Screwdriver
  36 reports
• The Tether™ 204H0300

  Vertebral Body Tethering System
  29 reports
• The Tether™ 211H6032

  Vertebral Body Tethering System
  6 reports
• The Tether™ 203H0012

  Vertebral Body Tethering System
  6 reports
• The Tether™ 211H6030

  Vertebral Body Tethering System
  4 reports
• The Tether™ 211H6035

  Vertebral Body Tethering System
  3 reports
• The Tether™ 211H6040

  Vertebral Body Tethering System
  2 reports
• The Tether™ 211H7035

  Vertebral Body Tethering System
  2 reports
• The Tether™ 211H7037

  Vertebral Body Tethering System
  2 reports
• The Tether™ 211H7040

  Vertebral Body Tethering System
  2 reports
• The Tether™ 211H6025

  Vertebral Body Tethering System
  1 report

Recent The Tether adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionAug 25, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT WHILE FINALIZING THE SECURING OF THE CORD WITH THE SET SCREW, THE SCREW FAILED TO ENGAGE WITH THE DRIVER; THE DRIVER WAS STRIPPED. A SECOND DRIVER WAS ALSO FOUND TO BE STRIPPED. THE SURGERY WAS COMPLETED USING A THIRD DRIVER WITH NO PATIENT HARM AND ONLY A TWO MINUTE PROCEDURAL DELAY. UPON MANUFACTURER INVESTIGATION, IT WAS DISCOVERED THAT BOTH TETHER DRIVERS HAD FRACTURED TIPS. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22890200 ↗
• MalfunctionAug 25, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT WHILE FINALIZING THE SECURING OF THE CORD WITH THE SET SCREW, THE SCREW FAILED TO ENGAGE WITH THE DRIVER; THE DRIVER WAS STRIPPED. A SECOND DRIVER WAS ALSO FOUND TO BE STRIPPED. THE SURGERY WAS COMPLETED USING A THIRD DRIVER WITH NO PATIENT HARM AND ONLY A TWO MINUTE PROCEDURAL DELAY. UPON MANUFACTURER INVESTIGATION, IT WAS DISCOVERED THAT BOTH TETHER DRIVERS HAD FRACTURED TIPS. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22890194 ↗
• MalfunctionAug 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT TWO TETHER SET SCREW DRIVER TIPS FRACTURED DURING A SURGERY. THE C-RINGS BROKE OFF IN THE TULIP HEAD OF THE TETHER SCREWS. THERE WAS NO PATIENT IMPACT; HOWEVER, THERE WAS A 30-45 MINUTE DELAY TO RETRIEVE THE BROKEN PIECES. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22874467 ↗
• MalfunctionAug 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT TWO TETHER SET SCREW DRIVER TIPS FRACTURED DURING A SURGERY. THE C-RINGS BROKE OFF IN THE TULIP HEAD OF THE TETHER SCREWS. THERE WAS NO PATIENT IMPACT; HOWEVER, THERE WAS A 30-45 MINUTE DELAY TO RETRIEVE THE BROKEN PIECES. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22874455 ↗
• 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 ↗
• MalfunctionJun 25, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT A STRIPPED TETHER SET SCREW DRIVER WAS FOUND DURING A SURGERY AFTER THE DRIVER FAILED TO ENGAGE THE SET SCREW WHILE SECURING THE CORD. THE SURGERY WAS COMPLETED WITH A SECOND DRIVER WITHOUT ANY PROCEDURAL DELAY OR PATIENT IMPACT. UPON MANUFACTURER INVESTIGATION, IT WAS DISCOVERED THAT THE TIP OF THE DRIVER WAS FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22328779 ↗
• 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 ↗
• 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 FOUR OF FOUR FOR THIS EVENT.

  Patient problems: Spinal Column Injury

  MAUDE report 20634375 ↗
• 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 ↗
• 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 ↗

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