MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. CORD 300 MM; THE TETHER - VERTEBRAL BODY TETHERING SYSTEM

Catalog Number	204H0300
Medical Device Problem Codes	Fracture (1260); Unintended Movement (3026)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	08/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
Event or Problem Description
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
Corrections in d9 and h3.Additional information in h6: investigation type, findings, and conclusions.Device evaluation: the retrieved components were examined macroscopically for signs of wear and damage.Stage i through stage iii analyses confirmed the presence of frayed fibers and abrasive wear.Frayed fibers could be caused by normal use of the device, occur during removal, interaction with the screw and set screw, or during abnormal loading conditions.Stage iii analysis utilized enzymatic cleaning to remove biological material from the specimen as confirmed by optical microscopy and atr-ftir.Atr-ftir showed that the spectrum of the cleaned cord of zbt009 was qualitatively nearly identical to that of an exemplar component, suggesting that the cord component has not experienced degradation.Root cause: a definitive root cause cannot be determined, but the failure of worsening of condition leading to revision could be attributed to over tightening of the cord during the initial procedure, unexpected growth patterns or unknown patient/surgical factors.Dhr review: the lot number was not reported and the device was not returned, therefore a dhr review is unable to be performed.Device usage: this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
Additional Manufacturer Narrative
Corrections in b5 and h6: device codes and results codes.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
Event or Problem Description
It was reported that a revision was performed to address a vbt with right thoracic curve progression and a broken cord.The cord and set screws were removed and replaced between t10 and l3.There were no complications during the revision.

• Brand Name: CORD 300 MM
• Common Device Name: THE TETHER - VERTEBRAL BODY TETHERING SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE, INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE, INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer Contact: teresa george ; 10225 westmoor dr.; westminster, CO 80021 ; 3035018506
• MDR Report Key: 20354712
• Report Number: 3012447612-2024-00405
• Device Sequence Number: 6545741
• Product Code: QHP
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: H190005
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 204H0300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 03/23/2026; 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female