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

Catalog Number	204H0300
Medical Device Problem Codes	Break (1069); Unintended Movement (3026)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	07/28/2024
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 revision surgery will be performed to release a tether cord between t11 and l2 because the patient has 16 degrees of over correction.The over correction was discovered during a 3 year post-operative follow-up visit.
Additional Manufacturer Narrative
Corrections in b5, d4: lot number and udi number, d9, g2, and h3.Additional information in d4: expiration date, h4, and h6: device code.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.Reference reports 3012447612-2024-00261 and 3012447612-2024-00309 through 3012447612-2024-00311.
Event or Problem Description
It was reported that a revision surgery was performed to release a tether cord between t11 and l2 because the patient has 16 degrees of overcorrection.The overcorrection was discovered during a 3 year post-operative follow-up visit.During the revision, the cord was found broken between t11 and t12.The cord between t11 and l2 and the screws between t11 and l1 were removed during the procedure.This is report one of four for this event.
Additional Manufacturer Narrative
H3: "device evaluation anticipated, but not yet begun" is erroneous and no longer applies.The device was evaluated.H6: additional method code: 4110.Corrections in h3.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 no pictures were provided to confirm cord breakage.The device was sent to exponent for evaluation.Exponent's analysis reported 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 zbt008 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 with the information provided.This event could possibly be attributed to unknown patient or surgical factors.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 revision surgery was performed to release a tether cord between t11 and l2 because the patient has 16 degrees of overcorrection.The overcorrection was discovered during a 3 year post-operative follow-up visit.During the revision, the cord was found broken between t11 and t12.The cord between t11 and l2 and the screws between t11 and l1 were removed during the procedure.This is report one of four for this event.

• 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: 20363537
• Report Number: 3012447612-2024-00261
• Device Sequence Number: 17859644
• Product Code: QHP
• UDI-Device Identifier: 00880304865068
• UDI-Public: (01)00880304865068(10)3036068
• 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: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/17/2025

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 Expiration Date: 05/30/2025
• Device Catalogue Number: 204H0300
• Device Lot Number: 3036068
• Was Device Available for Evaluation?: Yes
• 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; Not provided
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 11/07/2024; 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 14 YR
• Patient Sex: Female
• Patient Weight: 47 KG
• Patient Ethnicity: Non Hispanic