MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. LATERAL OFFSET CONNECTOR (10 MM L); VIRAGE OCT SPINAL FIXATION SYSTEM

Catalog Number	07.01727.001
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2022
Type of Reportable Event	Malfunction
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 3012447612-2022-00154 through 3012447612-2022-00156.
Event or Problem Description
It was reported that a portion of the tulip of a virage screw fractured, preventing full tightening of the construct at that level.A closure top at different level would not final tighten.The surgeon elected to leave both the screw and closure top in place in the patient.A 10mm offset connector was difficult to tighten and it was removed and replaced to complete the procedure.The surgeon felt the procedure was successful, but the patient will be monitored.This is report two 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 visual inspection revealed the closure top is jammed in the offset connector and is unable to be tightened using a virage final driver (07.01783.001 lot mc4418404).The virage screw and closure top which remain implanted were unable to be assessed.Potential cause root cause was unable to be determined.This event could possibly be attributed to wear through use over time or multiple sterilization cycles.Dhr review per dhr review, the connector was likely conforming when it left zimvie control.The dhr review for the screw and closure top in the subforms was unable to be performed as the lot number is not known.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 a portion of the tulip of a virage screw fractured, preventing full tightening of the construct at that level.A closure top at different level would not final tighten.The surgeon elected to leave both the screw and closure top in place in the patient.A 10mm offset connector was difficult to tighten and it was removed and replaced to complete the procedure.The surgeon felt the procedure was successful, but the patient will be monitored.This is report two of three for this event.

• Brand Name: LATERAL OFFSET CONNECTOR (10 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: 14701762
• Report Number: 3012447612-2022-00155
• Device Sequence Number: 2202373
• Product Code: KWP
• UDI-Device Identifier: 00889024328907
• UDI-Public: (01)00889024328907(10)T11268
• 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): 11/04/2022

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: 07.01727.001
• Device Lot Number: T11268
• 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: 05/19/2022
• Supplement Date Received by Manufacturer: 10/14/2022
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2021
• 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
• Patient Sex: Unknown