MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. VITAL MIS POLY 7.5X45MM; VITALITY SPINAL FIXATION SYSTEM

Catalog Number	824M7545
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	10/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed on a vital mis patient to address pain five days after the initial surgery.Follow-up x-rays revealed a hematoma as well as a migrated set screw and a loose set screw on the right side of the construct.Seven days post-operatively, the revision surgery was performed and the entire right side of the construct was removed and replaced.The left side of the construct was checked and found to have no problems.This is report three of four for this event.
Additional Manufacturer Narrative
D10: vital mis poly 7.5x45mm: pn 824m7545, ln sbm183051 - qty 1, vitality closure top: pn 07.02010.001, ln zb7739170 - qty 1, vital mis 5.5 ti rod perc crv 65mm: pn 815m1065, ln ct149553 - qty 1.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 3012447612-2024-00361 through 3012447612-2024-00364.
Event or Problem Description
It was reported that a revision surgery was performed on a vital mis patient to address pain five days after the initial surgery.Follow-up x-rays revealed a hematoma as well as a migrated set screw and a loose set screw on the right side of the construct.Seven days post-operatively, the revision surgery was performed and the entire right side of the construct was removed and replaced.The left side of the construct was checked and found to have no problems.This is report three of four for this event.
Additional Manufacturer Narrative
H6: additional method code: 4110.Additional information in h6: investigation type, findings, and conclusions.Device evaluation: the device was not returned, however x-ray images were provided which show that a closure top has migrated out of its screw.Root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to not fully seating the closure tops against the rods.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.

• Brand Name: VITAL MIS POLY 7.5X45MM
• 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: 20761844
• Report Number: 3012447612-2024-00363
• Device Sequence Number: 8587865
• Product Code: NKB
• UDI-Device Identifier: 00887868514258
• UDI-Public: (01)00887868514258(10)SBM183051
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203507
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2025

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: Lay User/Patient
• Device Catalogue Number: 824M7545
• Device Lot Number: SBM183051
• 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: 11/22/2024
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2024
• 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: Required Intervention; Other; Hospitalization
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic