MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. PROLIFT EXPANDABLE SPACER SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number 58-1228-0708D

Device Problems Malposition of Device (2616); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/01/2019

Event Type  Injury  

Event Description

Surgeon was implanting spinal cage.The cage was advanced, x-ray taken and surgeon determined cage was advanced too far, surgeon attempted to put back on cage inserter, cage inserter detached from cage implant.Surgeon was unsuccessful in attempts to retrieve cage.Vascular surgeon consulted.Ct scan completed.Pt returned to operating room for add'l surgery, vascular surgeon retrieved cage through an abdominal approach.Pt was extubated in operating room.Noted pt was moving all four extremities, pt transported to pacu for recovery.Fda safety report id# (b)(4).

• Brand Name: PROLIFT EXPANDABLE SPACER SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): ZIMMER BIOMET SPINE, INC. ; westminster CO 80021
• MDR Report Key: 8596777
• MDR Text Key: 144702438
• Report Number: MW5086494
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00190837030940
• UDI-Public: (01)00190837030940(10)CNW18061
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 58-1228-0708D
• Device Catalogue Number: 151-261
• Device Lot Number: AXO407
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 102