MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. VITAL MIS POLY 6.5X50MM; VITALITY SPINAL FIXATION SYSTEM

Catalog Number 824M6550

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/02/2024

Event Type  Injury  

Event Description

It was reported that at a follow-up appointment following a left l 4/5 tlif, it was found that a vital set screw migrated out of the left l4 vital 6.5x50 screw.This surgery had been an extension of fusion to l4/5 with a prior alif at l5/s1 that had used competitive pedicle screws.A revision surgery was performed to remove and replace the screw and set screw with competitive products.This is report two of two for this event.

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 3012447612-2024-00072.

• Brand Name: VITAL MIS POLY 6.5X50MM
• Type of Device: 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: sabrina abla ; 10225 westmoor dr.; westminster, CO 80021 ; 7206965158
• MDR Report Key: 19186966
• MDR Text Key: 341117804
• Report Number: 3012447612-2024-00073
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 0088786851348
• UDI-Public: (01)0088786851348(10)SBM141999
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203507
• Exemption Number: 5645646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 824M6550
• Device Lot Number: SBM141999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2024
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN 70MM ROD
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic