MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. SCREW+SS 7.0MMX35MM; THE TETHER - VERTEBRAL BODY TETHERING SYSTEM

Catalog Number	211H7035
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Procode: qhp.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.Reference reports 3012447612-2022-00020 through 3012447612-2022-00026.
Event or Problem Description
It was reported a revision surgery was performed because the surgeon believed the tether cord had broken post-operatively.However, during the revision, the cord was found to be intact, but some of the set screws did not appear to be locked and were loose during removal, especially at l3.The cord and set screws were removed and replaced.This is report three of seven for this event.
Additional Manufacturer Narrative
Data was erroneously entered into h3; there are no changes from the initial report.Additional information in h4 and h6: component, investigation type, findings, and conclusions.Device evaluation: neither the closure top nor the screw was returned for evaluation.Root cause: root cause was unable to be determined.This event could possibly be attributed to unknown operational factors, patient factors, or post-op events.Dhr review: per dhr review, the part was likely conforming when it left zimvie 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 a revision surgery was performed because the surgeon believed the tether cord had broken post-operatively.However, during the revision, the cord was found to be intact, but some of the set screws did not appear to be locked and were loose during removal, especially at l3.The cord and set screws were removed and replaced.This is report three of seven for this event.

• Brand Name: SCREW+SS 7.0MMX35MM
• 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.; na; westminster CO 80021
• Manufacturer Contact: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 13334427
• Report Number: 3012447612-2022-00022
• Device Sequence Number: 17175667
• Product Code: QHP
• UDI-Device Identifier: 00880304865266
• UDI-Public: (01)00880304865266(17)250430(10)303381
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: H190005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2022

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: 04/30/2025
• Device Catalogue Number: 211H7035
• Device Lot Number: 3033881
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2021
• Supplement Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 01/24/2022
• Supplement Report FDA Received Date: 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2020
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Sex: Unknown