MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. POLYAXIAL SCREW (DIA. 3.5 MM X 12 MM L); VIRAGE OCT SPINAL FIXATION SYSTEM

Catalog Number 07.01702.005

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Failure of Implant (1924); Neck Pain (2433)

Event Date 01/03/2022

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.

Event Description

It was reported that the tulip disassembled from a virage screw about 7 months post-operatively.The patient is experiencing neck pain but the surgeon does not plan on revising the screw at this time.

Manufacturer Narrative

Inspection: the product was not returned, so an evaluation is unable to be performed.However, a photo of an mri scan was provided.The photo shows that the screw has disassembled, so the complaint is confirmed.Dhr review: the lot number was not provided, so the dhr was unable to be reviewed.Potential root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to unknow surgical/patient factors or post-op instructions not being followed by the patient.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 tulip disassembled from a virage screw about 7 months post-operatively.The patient is experiencing neck pain but the surgeon does not plan on revising the screw at this time.

• Brand Name: POLYAXIAL SCREW (DIA. 3.5 MM X 12 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: 13445264
• MDR Text Key: 286674654
• Report Number: 3012447612-2022-00031
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133556
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07.01702.005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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