MAUDE Adverse Event Report: ZIMMER BIOMET SPINE SEQUOIA CLOSURE TOP; SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2016

Event Type  Injury  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.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.This is report three of four for this event.Reference reports 3004485144-2016-00361 thru 3004485144-2016-00364.

Event Description

It was reported that three closure tops fractured during final tightening.Additionally, a pedicle screw disassembled while trying to further install it into the pedicle after initial placement within the same procedure.The three closure tops and pedicle screw were replaced.There were no reports of patient harm associated with this event, however the surgery was delayed by 45 minutes.

Manufacturer Narrative

Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.

Manufacturer Narrative

The returned closure tops were evaluated.The threads were deformed, likely related to cross-threading.A review of the manufacturing records did not identify any issues which would have contributed to this event.

• Brand Name: SEQUOIA CLOSURE TOP
• Type of Device: SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE; 310 interlocken parkway; suite 120; broomfield CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE; 310 interlocken parkway; suite 120; broomfield CO 80021
• Manufacturer Contact: geoffrey gannon ; 310 interlocken parkway; suite 120; broomfield, CO 80021 ; 3034437500
• MDR Report Key: 6168332
• MDR Text Key: 62184948
• Report Number: 3004485144-2016-00363
• 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,Followup
• Report Date: 06/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 3301-1
• Device Lot Number: 82WK
• Other Device ID Number: (01)00889024334861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2014
• 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
• Patient Age: 64 YR