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	Migration (4003)
Health Effect - Clinical Code	Fall (1848)
Date of Event	08/22/2022
Type of Reportable Event	Serious Injury
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 reports 3012447612-2022-00217 through 3012447612-2022-00219.
Event or Problem Description
It was reported that two virage screws loosened and one disassembled post-operatively after the patient may have fallen.A revision surgery was performed where the three screws were removed and replaced, and the construct was extended from levels c4 - t2 to c3 - t2.This is report three of three for this event.
Event or Problem Description
It was reported that two virage screws loosened and one disassembled post-operatively after the patient may have fallen.A revision surgery was performed where the three screws were removed and replaced, and the construct was extended from levels c4 - t2 to c3 - t2.This is report three of three for this event.
Additional Manufacturer Narrative
Corrections in d9 and h3.Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation device inspection revealed that two pieces from lot abq had cracks in the weld on one side.The third piece from lot abq had both welds broken, causing the lower housing to break into its two pieces and allowing the screw components to disassemble.The weld penetration depth was confirmed to be greater than minimum specification.Potential cause the root cause was unable to be determined.This event could possibly be attributed to the patient's fall or other unknown patient and operational factors.Dhr review per dhr review, the parts were likely conforming when they left zimvie control.Device use and compatibility 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. 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.; na; westminster CO 80021
• Manufacturer Contact: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 15530758
• Report Number: 3012447612-2022-00219
• Device Sequence Number: 6055475
• Product Code: KWP
• UDI-Device Identifier: 00889024320925
• UDI-Public: (01)00889024320925(10)ABQ
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133556
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2023

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: Health Professional
• Device Catalogue Number: 07.01702.007
• Device Lot Number: ABQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2022
• Supplement Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 10/03/2022
• Supplement Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2021
• 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
• Patient Sex: Unknown