MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. POLYAXIAL SCREW (DIA. 3.5 MM X 22 MM L); VIRAGE OCT SPINAL FIXATION SYSTEM

Catalog Number 07.01702.015

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 10/04/2023

Event Type  Injury  

Event Description

It was reported that during an x-ray approximately 1 week postoperatively, the c7 left screw showed a crack, and an x-ray approximately 2 months post-operatively showed that the tulip head fractured on two screws.A revision surgery is scheduled to remove the construct and replace with competitive product.This is report one of two for this event.

Manufacturer Narrative

E1 phone #: (b)(6).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.

• Brand Name: POLYAXIAL SCREW (DIA. 3.5 MM X 22 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.; westminster CO 80021
• Manufacturer Contact: sabrina abla ; 10225 westmoor dr.; westminster, CO 80021 ; 7206965158
• MDR Report Key: 18367596
• MDR Text Key: 331020394
• Report Number: 3012447612-2023-00397
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 00889024327085
• UDI-Public: (01)00889024327085(10)AAT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133556
• Exemption Number: 5645646
• 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
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 07.01702.015
• Device Lot Number: AAT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2022
• 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): Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic