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	11/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.Reference report 3012447612-2021-00460.
Event or Problem Description
It was reported that two screws broke apart after being final tightened intra-operatively.They screws were removed and replaced to complete the procedure without patient impacts.This is report two of two for this event.
Additional Manufacturer Narrative
Device evaluation: visual inspection revealed the weld has fractured on the housing of the screws.Potential cause: root cause was unable to be determined.This event could possibly be attributed to off-axis forces applied to the tulip head causing radial pressure on the tulip head leading to weld failure.Dhr review and related actions per dhr review, a weld certification was provided to zimvie at the time the product was received.Device use: 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 two screws broke apart after being final tightened intra-operatively.They screws were removed and replaced to complete the procedure without patient impacts.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.; na; westminster CO 80021
• Manufacturer Contact: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 13003953
• Report Number: 3012447612-2021-00461
• Device Sequence Number: 11969442
• Product Code: KWP
• UDI-Device Identifier: 00889024327009
• UDI-Public: (01)00889024327009(10)ABO
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K133556
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2022

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
• Device Lot Number: ABO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• 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: 11/19/2021
• Supplement Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 05/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2020
• 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: Male