MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. SCREW+SS 6.0MMX32.5MM; THE TETHER - VERTEBRAL BODY TETHERING SYSTEM

Catalog Number 211H6032

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

Patient Problem Loss of Range of Motion (2032)

Event Date 07/27/2021

Event Type  Injury  

Manufacturer Narrative

Product code: 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 3012447612-2021-00318 through 3012447612-2021-00337.

Event Description

It was reported that a tether construct was removed and replaced with a fusion construct from t3-l3 due to the patient's lack of flexibility.The initial tether construct was from t5-l1.This is report 17 of 20 for this event.

Event Description

It was reported that a tether construct was removed and replaced with a fusion construct from t3-l3 due to the patient's lack of flexibility.The initial tether construct was from t5-l1.This is report 17 of 20 for this event.

Manufacturer Narrative

Device evaluation: product was not returned and photos were not provided, so device evaluation could not be completed.Potential cause: root cause was unable to be determined.This event could possibly be attributed to unknown patient or operational factors.Dhr review: per dhr review, the part was likely conforming when it left zimmer biomet control.Device use: 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 6.0MMX32.5MM
• 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: 12388445
• MDR Text Key: 268876640
• Report Number: 3012447612-2021-00334
• Device Sequence Number: 1
• Product Code: QHP
• 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,Followup
• Report Date: 12/27/2021

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 Expiration Date: 12/31/2023
• Device Catalogue Number: 211H6032
• Device Lot Number: 2970360
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/02/2021
• Initial Date FDA Received: 08/30/2021
• Supplement Dates Manufacturer Received: 12/10/2021
• Supplement Dates FDA Received: 12/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2019
• 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: Female