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 Problems Fracture (1260); Difficult to Remove (1528)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 03/26/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 3012447612-2019-00190 thru 3012447612-2019-00192.

Event Description

It was reported that there were problems while installing three closure tops during surgery.The first one had a thread that sheared, so it was removed and replaced.The second closure top had a thread that sheared; however, it needed to be milled out during the removal process before being replaced.The hex drive feature of the third one stripped so it was not able to be removed or final tightened.There was a surgical delay greater than 30 minutes associated with this event, but there were no reported patient impacts associated with the delay.This is report two of three for this event.

Manufacturer Narrative

Additional information: methods, results, and conclusions - the device was not returned so an evaluation was unable to be performed, no results are available, and no conclusions can be drawn.A review of the dhr did not identify any manufacturing issues which would have contributed to this event.

Event Description

It was reported that there were problems while installing three closure tops during surgery.The first one had a thread that sheared, so it was removed and replaced.The second closure top had a thread that sheared; however, it needed to be milled out during the removal process before being replaced.The hex drive feature of the third one stripped so it was not able to be removed or final tightened.There was a surgical delay greater than 30 minutes associated with this event, but there were no reported patient impacts associated with the delay.This is report two of three 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: 8545207
• MDR Text Key: 142930667
• Report Number: 3012447612-2019-00191
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3301-1
• Device Lot Number: AAC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2018
• 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): Other