MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. OPEN IMPLANT CLOSURE TOP; 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 07/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The closure top was returned for evaluation.The threads were found to have fractured off.Based on the event description and the nature of the thread failure, it is likely the failure is due to misalignment between the closure top and pedicle screw tulip head.A review of the dhr did not identify any issues which would have contributed to this event.

Event Description

It was reported that two closure tops stripped during final tightening within surgery.The closure tops were removed and replaced with alternative closure tops to complete the procedure without reported patient impacts.This is report two of two for this event.

• Brand Name: OPEN IMPLANT CLOSURE TOP
• 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
• Manufacturer (Section G): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; na; westminster CO 80021
• Manufacturer Contact: ashley mcpherson ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3034437500
• MDR Report Key: 8189390
• MDR Text Key: 131166812
• Report Number: 3012447612-2018-01028
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K131980
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• 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: AAF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1