MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. SCREW+SS 7.0MMX40MM; THE TETHER - VERTEBRAL BODY TETHERING SYSTEM

Catalog Number 211H7040

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Insufficient Information (4580)

Event Date 12/29/2021

Event Type  Injury  

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 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 seven of seven for this event.

Event 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 seven of seven for this event.

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.

• Brand Name: SCREW+SS 7.0MMX40MM
• Type of Device: 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: 13334464
• MDR Text Key: 284351275
• Report Number: 3012447612-2022-00026
• Device Sequence Number: 1
• Product Code: QHP
• UDI-Device Identifier: 00880304865280
• UDI-Public: (01)00880304865280(17)231130(10)2970390
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: H190005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 211H7040
• Device Lot Number: 2970390
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/12/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/23/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization