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 Fracture (1260)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Date 07/05/2018

Event Type  Injury  

Manufacturer Narrative

Patient year of birth: 1950.(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 3012447612-2018-00631 thru 3012447612-2018-00634.

Event Description

It was reported that the threads of three closure tops fractured and one pedicle screw disassembled while being installed during surgery.An alternative pedicle screw and closure top were used to complete the procedure.The procedure was delayed greater than 30 minutes and it cannot be determined if all device fragments were removed from the patient.However, no injuries have been reported.This is report three of four for this event.

Manufacturer Narrative

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 the threads of three closure tops fractured and one pedicle screw disassembled while being installed during surgery.An alternative pedicle screw and closure top were used to complete the procedure.The procedure was delayed greater than 30 minutes and it cannot be determined if all device fragments were removed from the patient.However, no injuries have been reported.

• 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: 7746776
• MDR Text Key: 115917238
• Report Number: 3012447612-2018-00633
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: PK131980
• 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: 11/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• 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: 87QQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2016
• 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
• Patient Outcome(s): Other