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
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); Impaired Healing (2378)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tulip heads of two virage screws disassembled post-operatively, resulting in the patient needing a hard collar brace.This is report one of two for this event.
Additional 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.
Additional Manufacturer Narrative
Corrections in b5.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
Event or Problem Description
It was reported that the tulip heads of three virage screws disassembled post-operatively, resulting in the patient needing a hard collar brace.This is report one of three for this event.
Additional Manufacturer Narrative
H6: additional method code: 4109.Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: the device was not returned, however x-rays were provided which show that the screws have fractured and disassembled.Root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to unknown patient or surgical factors.Dhr review: the lot number was not provided, so the dhr was unable to be reviewed.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 or Problem Description
It was reported that the tulip heads of three virage screws disassembled post-operatively, resulting in the patient needing a hard collar brace.This is report one of three for this event.
Additional Manufacturer Narrative
H6: additional method code: 4110.Corrections in b5, d4: lot number, d9, h3, and h6: component code additional information in b2, d4: udi number, h4, and h6: impact, investigation type, findings, and conclusions.Device evaluation: the returned device matches the information in the complaint file and was examined.Visual inspection revealed the lower housing has fractured, resulting in the screw disassembling.Root cause: the root cause is being further investigated in an internal scar.Dhr review: the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left highridge medical¿s 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 or Problem Description
It was reported that the tulip heads of three virage screws disassembled post-operatively, resulting in the patient needing a hard collar brace.A revision surgery was performed to explant the screws.This is report one of three for this event.

• Brand Name: POLYAXIAL SCREW (DIA. 3.5 MM X 12 MM L)
• Common Device Name: 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: 18232416
• Report Number: 3012447612-2023-00373
• Device Sequence Number: 7160917
• Product Code: KWP
• UDI-Device Identifier: 00889024326989
• UDI-Public: (01)00889024326989(10)ABX
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K133556
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 07.01702.005
• Device Lot Number: ABX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 12/11/2023; 06/03/2024; 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic