MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. PLUG; EBI 5.5 HELICAL FLANGE SPINAL SYSTEM

Catalog Number 2000-1005

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Unspecified Infection (1930); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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 reports 3012447612-2022-00041 through 3012447612-2022-00045.

Event Description

It was reported that the patient underwent a unilateral fusion on the right side of l4/5 following a car accident.Two 2000-2445 screws, two 2000-1005 closure tops, and one 2000-5140 rod were installed.Following the surgery, the patient experienced pain, progressive disability, an irreversible bone infection, and "legs wasting away." the patient alleges to be allergic to zinc chloride and sensitive to cobalt.The implants were removed in a revision surgery.This is report one of five for this event.

Manufacturer Narrative

Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: product not returned, and photos and x-rays were not provided.Root cause: root cause was unable to be determined.This event could possibly be attributed to unknown patient factors, trauma and operational factors.Dhr review: lot numbers are not known, so dhr reviews could not be performed.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 Description

It was reported that the patient underwent a unilateral fusion on the right side of l4/5 following a car accident.Two 2000-2445 screws, two 2000-1005 closure tops, and one 2000-5140 rod were installed.Following the surgery, the patient experienced pain, progressive disability, an irreversible bone infection, and "legs wasting away." the patient alleges to be allergic to zinc chloride and sensitive to cobalt.The implants were removed in a revision surgery.This is report one of five for this event.

• Brand Name: PLUG
• Type of Device: EBI 5.5 HELICAL FLANGE SPINAL SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; na; westminster CO 80021
• Manufacturer Contact: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 13559917
• MDR Text Key: 288854973
• Report Number: 3012447612-2022-00041
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 2000-1005
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Disability
• Patient Sex: Male