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

Catalog Number	204H0300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); Spinal Column Injury (2081); Insufficient Information (4580)
Date of Event	08/01/2024
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 revision surgery was performed to address a post-operative cord breakage.Further information regarding patient impact is unavailable at this time.
Additional Manufacturer Narrative
Corrections in b5, d4: lot number, and h6: patient codes.Additional information in a1, d4: expiration date and udi, d6a, d6b, h4, and h6: component, investigation type, findings, and conclusions.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 tether revision surgery was performed to address a post-operative cord breakage.Approximately 6 months post-operatively, the patient returned for consultations for pain in the thoracolumnar area.An x-ray was then performed that revealed a cord rupture at the t12 screw with loss of correction between t11 and l1.The consequences of this rupture include pain, loss of correction, and a revision surgery that involved explanting the ruptured cord and re-implanting a new one between t7 and l3.
Additional Manufacturer Narrative
H6: additional method code: 4110.Additional information in h6: investigation type, findings, and conclusions.Device evaluation: the device was not returned, so an evaluation is unable to be performed.A video and an x-ray were provided, but they do not show the broken cord.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.The surgeon also mentioned that the growth of the patient was greater than expected, which may have resulted in extra stress on the cord and contributed to this issue.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 medical¿s control.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.
Event or Problem Description
It was reported that a tether revision surgery was performed to address a post-operative cord breakage.Approximately 6 months post-operatively, the patient returned for consultations for pain in the thoracolumnar area.An x-ray was then performed that revealed a cord rupture at the t12 screw with loss of correction between t11 and l1.The consequences of this rupture include pain, loss of correction, and a revision surgery that involved explanting the ruptured cord and re-implanting a new one between t7 and l3.

• 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: 20152876
• Report Number: 3012447612-2024-00250
• Device Sequence Number: 4263301
• Product Code: QHP
• UDI-Device Identifier: 00880304865068
• UDI-Public: (01)00880304865068(17)251130(10)3049377
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: H190005
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/19/2024

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: 11/29/2025
• Device Catalogue Number: 204H0300
• Device Lot Number: 3049377
• 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; Not provided
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 10/28/2024; 12/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2021
• 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: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic