MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. POLYAXIAL SCREW, DIA. 6.5MM X 40MM; VITALITY SPINAL FIXATION SYSTEM

Catalog Number	701M6540
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed to address a closure top that migrated out of the screw at s1.At the patient's post-operative follow-up appointment, the x-ray revealed the closure top was backing out of the screw.The construct was from l2-s1.Patient was revised with a new screw at the s1 level with all new closure tops on that side of the construct.This is report two of two for this event.
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 3012447612-2022-00173.
Additional Manufacturer Narrative
Corrections in h3.Additional information in h6: component, investigation type, findings, and conclusions.Inspection: visual inspection revealed no clear issues with the devices.No x-ray images were provided for review.The complaint remains unrefuted for post-op migration of the closure top.Dhr review the dhrs were reviewed.There are no indications of manufacturing issues which would have contributed to this event and the devices were likely conforming when they left zimvie¿s control.Potential root cause a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to the closure top not being tightened enough during the initial surgery.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.
Event or Problem Description
It was reported that a revision surgery was performed to address a closure top that migrated out of the screw at s1.At the patient's post-operative follow-up appointment, the x-ray revealed the closure top was backing out of the screw.The construct was from l2-s1.Patient was revised with a new screw at the s1 level with all new closure tops on that side of the construct.This is report two of two for this event.

• Brand Name: POLYAXIAL SCREW, DIA. 6.5MM X 40MM
• Common Device Name: VITALITY 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: 14983058
• Report Number: 3012447612-2022-00174
• Device Sequence Number: 20076976
• Product Code: NKB
• UDI-Device Identifier: 00880304867505
• UDI-Public: (01)00880304867505(10)T11392
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K171907
• 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: Health Professional,Distributor
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 701M6540
• Device Lot Number: T11392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2022
• 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: 06/16/2022
• Supplement Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 07/11/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2021
• 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: Female