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

Catalog Number 204H0300

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 10/05/2022

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed to replace a tether cord that broke in two places post-operatively after the patient went horseback riding.

Manufacturer Narrative

Procode: qhp.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.

Manufacturer Narrative

Corrections in d4: udi number and h3.Additional information in d4: expiration date, h4, and h6: component, investigation type, findings, and conclusions.Device evaluation: visual inspection revealed that the cord was fractured in multiple pieces.Dhr review: per dhr review, the part was likely conforming when it left zimvie control.Device use: this device is used for treatment.Potential cause: root cause was unable to be determined.This event could possibly be attributed to wear through use over time or multiple sterilization cycles.A follow-up report will be submitted if new information is received that changes the information provided in this report.

Event Description

It was reported that a revision surgery was performed to replace a tether cord that broke in two places post-operatively after the patient went horseback riding.

• Brand Name: CORD 300 MM
• 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: 15831053
• MDR Text Key: 304001609
• Report Number: 3012447612-2022-00268
• Device Sequence Number: 1
• Product Code: QHP
• UDI-Device Identifier: 00880304865068
• UDI-Public: (01)00880304865068(17)230831(10)2966796
• 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: 02/16/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 204H0300
• Device Lot Number: 2966796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/25/2022
• Initial Date FDA Received: 11/19/2022
• Supplement Dates Manufacturer Received: 02/03/2023
• Supplement Dates FDA Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2018
• 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