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

Catalog Number	204H0300
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	05/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medwatch (b)(4) was also submitted by the reporter for this incident and is attached.D10: pn 211h6030, ln 3049435 - screw+ss 6.0 mm x 30 mm, pn 211h6032, ln 30338803 - screw+ss 6.0 mm x 32.5 mm, pn 211h6035, ln 30051300 - screw+ss 6.0 mm x 35 mm, pn 211h6037, ln 3034396 - screw+ss 6.0 mm x 37.5 mm.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 revision surgery was performed due to overcorrection; the cord was removed from levels t10-l2.The patient experienced overcorrection of 16 degrees for the first time approximately 6 months post-op and the decision was made to monitor until the next follow-up visit was complete.The follow-up visit approximately 14 months later showed progression of overcorrection to 21 degrees.Then the decision was made to perform the revision.
Additional Manufacturer Narrative
H3: "device evaluation anticipated, but not yet begun" is erroneous and no longer applies.The device was evaluated.Corrections in h3.Additional information in h4 and h6: component, investigation type, findings, and conclusions.Device evaluation: the device was sent to exponent for evaluation.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 zbt007 was qualitatively nearly identical to that of an exemplar component, suggesting that the cord component has not experienced degradation.Additionally an x-ray image was provided, but it could not confirm the patient was experiencing overcorrection from the device.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 (b)(6) 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 due to overcorrection; the cord was removed from levels t10-l2.The patient experienced overcorrection of 16 degrees for the first time approximately 6 months post-op and the decision was made to monitor until the next follow-up visit was complete.The follow-up visit approximately 14 months later showed progression of overcorrection to 21 degrees.Then the decision was made to perform the revision.

• 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: 19785184
• Report Number: 3012447612-2024-00175
• Device Sequence Number: 15523571
• Product Code: QHP
• UDI-Device Identifier: 00880304865068
• UDI-Public: (01)00880304865068(17)251130(10)3049376
• 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
• Device Explanted Year: 2024
• 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): 12/16/2024

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: 3049376
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/27/2024
• 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: 07/19/2024
• Supplement Report FDA Received Date: 12/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2021
• 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: Female
• Patient Weight: 49 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White