MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. POLYAXIAL SCREW (DIA. 5.5 MM X 30 MM L); VIRAGE OCT SPINAL FIXATION SYSTEM

Catalog Number 07.01708.020

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/11/2022

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 shaft of a virage screw broke intra-operatively when the surgeon applied too much force to the screwdriver by hand when he was going to detach the screwdriver from the screw.The tulip was recovered, but the shaft remains implanted in the patient.The patient was not harmed.

Event Description

It was reported that the shaft of a virage screw broke intra-operatively when the surgeon applied too much force to the screwdriver by hand when he was going to detach the screwdriver from the screw.The tulip was recovered, but the shaft remains implanted in the patient.The patient was not harmed.

Manufacturer Narrative

Additional information in h6: component, investigation type, findings, and conclusions.Inspection the product was not returned and no photos were provided, so an evaluation is unable to be performed.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 off-axis or excessive forces applied during use.Device usage this device is used for treatment.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.

• Brand Name: POLYAXIAL SCREW (DIA. 5.5 MM X 30 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: 15566152
• MDR Text Key: 301467254
• Report Number: 3012447612-2022-00225
• 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: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07.01708.020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2023
• 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
• Patient Sex: Male
• Patient Weight: 82 KG