MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. ZYSTON STRAIGHT 7H X 20LX10W LORDOTIC SPACER; ZYSTON STRAIGHT SPACER SYSTEM

Catalog Number 14-534187

Device Problem Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/29/2018

Event Type  malfunction  

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 the threads of a spacer were cross-threaded while being attached to the mating inserter.An alternative spacer was used to complete the procedure without reported patient impacts.

Manufacturer Narrative

Udi number: (b)(4).Additional information: method, results, and conclusions - the device was returned and evaluated.The threads were seen to be damaged.It is likely the inserter was off-axis or misaligned when attempting to connect with the threads of the spacer.This would cause the peek threads to strip.A review of the manufacturing records did not identify any issues which would have contributed to this event.

Event Description

It was reported that the threads of a spacer were cross-threaded while being attached to the mating inserter.An alternative spacer was used to complete the procedure without reported patient impacts.

• Brand Name: ZYSTON STRAIGHT 7H X 20LX10W LORDOTIC SPACER
• Type of Device: ZYSTON STRAIGHT SPACER 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: 8108657
• MDR Text Key: 128567983
• Report Number: 3012447612-2018-00953
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112014
• 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: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14-534187
• Device Lot Number: 069540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2017
• 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