MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. SEQUOIA OPEN CLOSURE, 5.5M, TOP TI; SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM

Catalog Number 3301-1

Device Problem Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/02/2020

Event Type  malfunction  

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.Reference reports: 3012447612-2020-00591 to 3012447612-2020-00594.

Event Description

Two pathfinder nxt closure tops and screws stripped during tightening within surgery.They were removed and replaced with new screws and closure tops to complete the procedure.There were no reported patient impacts.This is report one of four for this event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information: h3, h6 (methods, results, conclusions).The complaint is confirmed for the path finder nxt implant for the reported failure of stripped during implantation.Visual inspection found the closure tops have threads that are damaged.The device was likely conforming when it left zimmer biomet's control.Currently, no action is recommended.

Event Description

Two pathfinder nxt closure tops and screws stripped during tightening within surgery.They were removed and replaced with new screws and closure tops to complete the procedure.There were no reported patient impacts.This is report one of four for this event.

• Brand Name: SEQUOIA OPEN CLOSURE, 5.5M, TOP TI
• Type of Device: SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 10785896
• MDR Text Key: 214580900
• Report Number: 3012447612-2020-00591
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00889024334861
• UDI-Public: (01)00889024334861(10)AAY
• Combination Product (y/n): N
• PMA/PMN Number: K131980
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3301-1
• Device Lot Number: AAY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1