MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. SCREW+SS 6.0MMX25MM; THE TETHER - VERTEBRAL BODY TETHERING SYSTEM

Catalog Number	211H6025
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	08/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 revision surgery was performed to address overcorrection of a tether construct.The set screws were removed from t5-t6 and the cord was removed from t5-t7.An overcorrection was originally measured at 10 degrees during the subject's 1 year visit and was monitored until the next visit.At the next visit approximately 10 weeks later, the misalignment was re-evaluated and changed to reflect the continuing overcorrection, now at 16 degrees near the most proximal end of the construct.This is report two of four for this event.
Additional Manufacturer Narrative
If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.Reference reports 3012447612-2023-00319 through 3012447612-2023-00322.
Event or Problem Description
It was reported that a revision surgery was performed to address overcorrection of a tether construct.The set screws were removed from t5-t6 and the cord was removed from t5-t7.An overcorrection was originally measured at 10 degrees during the subject's 1 year visit and was monitored until the next visit.At the next visit approximately 10 weeks later, the misalignment was re-evaluated and changed to reflect the continuing overcorrection, now at 16 degrees near the most proximal end of the construct.This is report two of four for this event.
Additional Manufacturer Narrative
H3: "device evaluation anticipated, but not yet begun (02)" no longer applies but cannot be deleted.H6 additional investigation type code: 4109 and 4110.Inspection: an 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.Further 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 was qualitatively nearly identical to that of an exemplar component, suggesting that the cord component has not experienced degradation.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.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.
Event or Problem Description
It was reported that a revision surgery was performed to address overcorrection of a tether construct.The set screws were removed from t5-t6 and the cord was removed from t5-t7.An overcorrection was originally measured at 10 degrees during the subject's 1 year visit and was monitored until the next visit.At the next visit approximately 10 weeks later, the misalignment was re-evaluated and changed to reflect the continuing overcorrection, now at 16 degrees near the most proximal end of the construct.This is report two of four for this event.

• Brand Name: SCREW+SS 6.0MMX25MM
• 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: sabrina abla ; 10225 westmoor dr.; westminster, CO 80021 ; 7206965158
• MDR Report Key: 17939969
• Report Number: 3012447612-2023-00320
• Device Sequence Number: 12375818
• Product Code: QHP
• UDI-Device Identifier: 00880304864917
• UDI-Public: (01)00880304864917(17)250531(10)3036471
• 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: 2023
• 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,Followup
• Report Date (Section B): 06/06/2024

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: Health Professional
• Device Expiration Date: 05/30/2025
• Device Catalogue Number: 211H6025
• Device Lot Number: 3036471
• Was Device Available for Evaluation?: Yes
• 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: 10/16/2023
• Supplement Report FDA Received Date: 03/08/2024; 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2020
• 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
• Patient Age: 12 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic