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

Catalog Number	204H0300
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	04/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4: the remainder of the udi number is unknown because the lot number is not available.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 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.
Event or Problem Description
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.
Additional Manufacturer Narrative
Additional information in h6: investigation type, findings, and conclusions.Device evaluation: no x-ray images were provided, therefore curve overcorrection could not be confirmed.Additionally, the device was not returned and no photos were provided, so an evaluation is unable to be performed.Root cause: this event could possibly be attributed to unknown patient or surgical factors.Dhr review: lot information was not provided, therefore a dhr review could not be completed.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.Reference reports 3012447612-2025-00162 through 3012447612-2025-00170.

• 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: 21969357
• Report Number: 3012447612-2025-00162
• Device Sequence Number: 8160679
• Product Code: QHP
• UDI-Device Identifier: 00880304865068
• UDI-Public: (01)00880304865068
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: H190005
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2025

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
• Was Device Available for Evaluation?: No
• 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: 05/06/2025
• Supplement Report FDA Received Date: 08/08/2025
• 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: Unknown
• Patient Ethnicity: Non Hispanic