MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. SEQUOIA TI POLY SCREW ASSX45; SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM

Catalog Number 3306-6545

Device Problems Malposition of Device (2616); Detachment of Device or Device Component (2907)

Patient Problem Tissue Damage (2104)

Event Date 10/19/2019

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.

Event Description

It was reported that during a revision surgery to reposition a screw that had initially been positioned incorrectly, the screw disassembled.They created a new channel and inserted a larger screw to complete the procedure.There were no reported surgical delays or additional patient impacts.

Manufacturer Narrative

Additional information in d4 (udi), h4, h6 (method, results, and conclusions).The screw was not returned for evaluation, so no results are available and no conclusions can be drawn.A review of the dhr did not find any issues which would have contributed to this event.

Event Description

It was reported that during a revision surgery to reposition a screw that had initially been positioned incorrectly, the screw disassembled.They created a new channel and inserted a larger screw to complete the procedure.There were no reported surgical delays or additional patient impacts.

• Brand Name: SEQUOIA TI POLY SCREW ASSX45
• 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: 9338728
• MDR Text Key: 166932371
• Report Number: 3012447612-2019-00442
• Device Sequence Number: 1
• Product Code: NKB
• 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: 03/03/2020

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: 3306-6545
• Device Lot Number: T09343
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/19/2019
• Initial Date FDA Received: 11/18/2019
• Supplement Dates Manufacturer Received: 02/03/2020
• Supplement Dates FDA Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention