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

Catalog Number	204H0300
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Failure of Implant (1924); Deformity/ Disfigurement (2360)
Date of Event	12/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reference voluntary medwatch mw5149325 (attached) for this event.Without a product return, no product evaluation is able to be conducted.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 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.
Additional Manufacturer Narrative
H6 additional investigation type code: 4110.Corrections in a2 and g1.Additional information in h6: component, investigation type, findings, and conclusions.Inspection the device was not returned, x-ray images were provided but the complaint is unrefuted for overcorrection as pre-op x-rays were not provided.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.Potential root cause a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to unknown patient or surgical factors.Device usage this device is used for treatment.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.Reference reports (b)(4).
Event or Problem Description
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.

• Brand Name: CORD 300MM
• 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: 18591778
• Report Number: 3012447612-2024-00013
• Device Sequence Number: 18188432
• Product Code: QHP
• UDI-Device Identifier: 00880304865068
• UDI-Public: (01)00880304865068(17)250131(10)3020936
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2024

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 Expiration Date: 01/30/2025
• Device Catalogue Number: 204H0300
• Device Lot Number: 3020936
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/26/2024
• Supplement Report FDA Received Date: 07/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2020
• 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: 11 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White