MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. POLYAXIAL SCREW (DIA. 3.5 MM X 30 MM L); VIRAGE OCT SPINAL FIXATION SYSTEM

Catalog Number	07.01702.023
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during final tightening of a c4/c7 fixation, an abnormal sound was observed, and found that two virage screws' housings were fractured at the welds.There was a 30-minute delay to remove the broken screws and replace them with new screws.There was no impact on the patient.This is report two of two for this event.
Additional Manufacturer Narrative
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.Reference report 3012447612-2024-00136.
Event or Problem Description
It was reported that during final tightening of a c4/c7 fixation, an abnormal sound was observed, and found that two virage screws' housings were fractured at the welds.There was a 30-minute delay to remove the broken screws and replace them with new screws.There was no impact on the patient.This is report two of two for this event.
Additional Manufacturer Narrative
Corrections in d9, g1, and h3.Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: the returned device matches the information in the complaint file and was examined.Visual inspection revealed the weld has fractured on the lower housing of the screw, resulting in the screw disassembling.A dimensional inspection of the weld depth was performed on a smartscope (id 0444 cal.Due 5/16/2025).The measurements are depicted in the attached photos and were set at the minimum allowable depth of.010".The weld depth exceeds the minimum requirement per drawing 07.01702.000 rev.D.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.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.

• Brand Name: POLYAXIAL SCREW (DIA. 3.5 MM X 30 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: 19606522
• Report Number: 3012447612-2024-00137
• Device Sequence Number: 6359613
• Product Code: KWP
• UDI-Device Identifier: 00889024327160
• UDI-Public: (01)00889024327160(10)AAI
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2024

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: 07.01702.023
• Device Lot Number: AAI
• 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
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2019
• 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
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic