MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. VITAL POLYAXIAL ILIAC SCREW, UNKNOWN TYPE OR SIZE; VITALITY SPINAL FIXATION SYSTEM

Catalog Number 704MXXXX OR 705MXXXX

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

Patient Problem Insufficient Information (4580)

Event Date 01/24/2024

Event Type  Injury  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.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 report 3012447612-2024-00042.

Event Description

It was reported a revision surgery was performed to address two vital polyaxial iliac screws that loosened in the bone postoperatively.During the revision, the surgeon added two additional screws and used offset connectors to attach them to the existing construct.Patient impacts beyond the revision surgery are currently unknown.This is report two of two for this event.

• Brand Name: VITAL POLYAXIAL ILIAC SCREW, UNKNOWN TYPE OR SIZE
• 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: 18917475
• MDR Text Key: 337818259
• Report Number: 3012447612-2024-00043
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K171907
• Exemption Number: 5645646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 704MXXXX OR 705MXXXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic