MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. POLYAXIAL SCREW (DIA. 3.5 MM X 14 MM L); VIRAGE OCT SPINAL FIXATION SYSTEM

Catalog Number	07.01702.007
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2024
Type of Reportable Event	Malfunction
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.Reference report 3012447612-2024-00184.
Event or Problem Description
It was reported that after final tightening, the virage construct was inspected and two virage screws were found to have fractured.They were replaced with screws of a larger diameter and the surgery was completed without patient harm, although there was a 15 minute delay to the procedure.This is report two of two for this event.
Additional Manufacturer Narrative
D4 udi number: only the gtin is available since the lot number was not provided.Additional information in d4: udi number h6: component, investigation type, findings, and conclusions.Inspection the device was not returned and no photos were provided, so an evaluation is unable to be performed.Dhr review the lot number was not reported and the device was not returned, therefore a dhr review is unable to be performed.Potential root cause a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to excessive torque applied to the closure top during final tightening.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.Reference report 3012447612-2024-00184.
Event or Problem Description
It was reported that after final tightening, the virage construct was inspected and two virage screws were found to have fractured.They were replaced with screws of a larger diameter and the surgery was completed without patient harm, although there was a 15 minute delay to the procedure.This is report two of two for this event.

• Brand Name: POLYAXIAL SCREW (DIA. 3.5 MM X 14 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: teresa george ; 10225 westmoor dr.; westminster, CO 80021 ; 3035018506
• MDR Report Key: 19866826
• Report Number: 3012447612-2024-00185
• Device Sequence Number: 8111267
• Product Code: KWP
• UDI-Device Identifier: 00889024327009
• UDI-Public: (01)00889024327009
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K133556
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 07.01702.007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/30/2024
• Supplement Report FDA Received Date: 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN VIRAGE RODS AND CLOSURE TOPS.
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic