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

Catalog Number	204H0300
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.
Event or Problem Description
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.
Additional Manufacturer Narrative
Corrected information in h3.Additional information in h6: method, results, and conclusions codes.The complaint is confirmed for one (1) of one (1) returned the tether cord 300mm (pn 204h0300) for the failure of fracture.This device is used for treatment.No medical records were provided with the complaint.Inspection the returned device matches the information in the complaint file and was examined.Visual inspection revealed the cord is fractured.Dhr review the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left highridge¿s control.Device labeling: the tether instructions for use (ifu0021-0117-us-en-rev 05 2023-04) was reviewed and contains the following information related to this issue: "possible complications below is a list of the potential adverse effects (i.E., complications) associated with the use of the device.Potential device or procedure-related adverse events (aes).Overcorrection of the coronal deformity, potentially requiring revision or removal of implants.Bending, fracturing, fraying, kinking, loosening, bending, or breaking of any or all implant components" root cause: this event could be attributed to unknown patient or surgical factors.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.
Event or Problem Description
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.

• Brand Name: CORD 300MM
• Common Device Name: 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: 22328664
• Report Number: 3012447612-2025-00249
• Device Sequence Number: 9436635
• Product Code: QHP
• UDI-Device Identifier: 00880304865068
• UDI-Public: (01)00880304865068(10)270717(10)3122048
• 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 Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2025

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
• Device Lot Number: 3122048
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 11/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2022
• 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 Age: 14 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic