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

Catalog Number 204H0300

Device Problem Fracture (1260)

Patient Problems Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/16/2022

Event Type  Injury  

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.Procode: qhp.

Event Description

It was reported that a revision surgery was performed to replace a broken cord that was causing the patient pain and increased deformity; the perception was the curve had come back partially since the initial surgery.The cord had separated between t11/12 and t12/l1; it is suspected the cord may have been damaged at t10/11.This was found during the patient's one year follow-up.

Event Description

It was reported that a revision surgery was performed to replace a broken cord that was causing the patient pain and increased deformity; the perception was the curve had come back partially since the initial surgery.The cord had separated between t11/12 and t12/l1; it is suspected the cord may have been damaged at t10/11.This was found during the patient's one year follow-up.

Manufacturer Narrative

Device evaluation: visual inspection revealed that the cord was fractured.Potential cause: root cause was unable to be determined.This event could possibly be attributed to post-op trauma or unknown operational issues.Dhr review: per dhr review, the part was likely conforming when it left zimvie control.Device use : 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.

• Brand Name: CORD 300MM
• 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: 14074199
• MDR Text Key: 289012034
• Report Number: 3012447612-2022-00100
• Device Sequence Number: 1
• Product Code: QHP
• UDI-Device Identifier: 00880304865068
• UDI-Public: (01)00880304865068(17)240630(10)3003481
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/18/2023

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 Catalogue Number: 204H0300
• Device Lot Number: 3003481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/17/2022
• Initial Date FDA Received: 04/11/2022
• Supplement Dates Manufacturer Received: 01/13/2023
• Supplement Dates FDA Received: 01/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2019
• 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): Hospitalization; Required Intervention
• Patient Sex: Male