MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. POLYAXIAL SCREW (DIA. 3.5 MM X 16 MM L); VIRAGE OCT SPINAL FIXATION SYSTEM

Catalog Number 07.01702.009

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/25/2022

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.Reference report 3012447612-2022-00138.

Event Description

It was reported that the housing threads on two virage screws were damaged while the closure tops were being installed into them intra-operatively.Both screws were removed and replaced to complete the procedure.There was a delay, but without patient impacts.This is report one of two for this event.

Manufacturer Narrative

Corrections in d9 and h3.Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: visual inspection revealed that the upper corner of the tulip head threading was stripped on each screw.There was no visible damage to the screw threading.Root cause: root cause was unable to be determined.This event could possibly be attributed to inserting the closure tops off-axis into the tulip head.Dhr review: per dhr review, the part was likely conforming when it left zimvie control.Device usage: this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.

Event Description

It was reported that the housing threads on two virage screws were damaged while the closure tops were being installed into them intraoperatively.Both screws were removed and replaced to complete the procedure.There was a delay, but without patient impacts.This is report one of two for this event.

• Brand Name: POLYAXIAL SCREW (DIA. 3.5 MM X 16 MM L)
• Type of Device: VIRAGE OCT SPINAL FIXATION 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: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 14463208
• MDR Text Key: 294657020
• Report Number: 3012447612-2022-00137
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 00889024327023
• UDI-Public: (01)00889024327023(10)AAX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133556
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07.01702.009
• Device Lot Number: AAX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2020
• 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 Sex: Male