MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. SCREW VBT ASSY, UNKNOWN SIZE; THE TETHER - VERTEBRAL BODY TETHERING SYSTEM

Catalog Number 211H60XX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

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.Reference reports 3012447612-2023-00129 through 3012447612-2023-00133.

Event Description

It was reported that a tether patient underwent a revision surgery to be converted to a fusion and the cord broke post-operatively.No further information has been provided.This is report three of five for this event.

Manufacturer Narrative

Corrections in g1.Additional information in h6: component, investigation type, findings, and conclusions.Inspection: the device was not returned and no photos were provided, so an evaluation is unable to be performed.Dhr review: the lot number was not provided, so the dhr was unable to be reviewed.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 Description

It was reported that a tether patient underwent a revision surgery to be converted to a fusion and the cord broke postoperatively.No further information has been provided.This is report three of five for this event.

• Brand Name: SCREW VBT ASSY, UNKNOWN SIZE
• 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: 16843879
• MDR Text Key: 314283189
• Report Number: 3012447612-2023-00131
• Device Sequence Number: 1
• Product Code: CET
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H190005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/01/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 211H60XX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/07/2023
• Initial Date FDA Received: 05/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic