MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. POLYAXIAL SCREW, DIA. 5.5MM X 45MM; VITALITY SPINAL FIXATION SYSTEM

Catalog Number	701M5545
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/17/2024
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.
Event or Problem Description
It was reported that a vitality polyaxial screw was fractured mid-shaft at l4.This was discovered during a revision surgery to extend from l4/5 to l5/s and the doctor was only able to remove from the middle of the shaft to the head.There was no patient impact; however there was a 30 minute delay.
Additional Manufacturer Narrative
Additional information in h6: investigation type, findings, and conclusions.Device evaluation: the device was not returned and no photos were provided, so an evaluation is unable to be performed.Root cause: a definitive root cause cannot be determined, but excessive or off-axis forces applied to the screw during insertion or removal could cause the screw shaft to fracture.Additionally, inadequate bone preparation could cause the screw to become embedded in hard bone and unable to be removed.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.
Event or Problem Description
It was reported that a vitality polyaxial screw was fractured mid-shaft at l4.This was discovered during a revision surgery to extend from l4/5 to l5/s and the doctor was only able to remove from the middle of the shaft to the head.There was no patient impact; however there was a 30 minute delay.

• Brand Name: POLYAXIAL SCREW, DIA. 5.5MM X 45MM
• 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.; westminster CO 80021
• Manufacturer Contact: teresa george ; 10225 westmoor dr.; westminster, CO 80021 ; 3035018506
• MDR Report Key: 20664580
• Report Number: 3012447612-2024-00315
• Device Sequence Number: 7211288
• Product Code: NKB
• UDI-Device Identifier: 00880304867093
• UDI-Public: (01)00880304867093(10)T11493
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171907
• 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): 04/27/2025

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: Lay User/Patient
• Device Catalogue Number: 701M5545
• Device Lot Number: T11493
• Was Device Available for Evaluation?: No
• 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: 11/12/2024
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2021
• 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
• Patient Ethnicity: Non Hispanic