MAUDE Adverse Event Report: AMENDIA ZEUS; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number 5-100928

Device Problems Fracture (1260); Difficult to Insert (1316); Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/23/2014

Event Type  malfunction  

Event Description

It was reported that the peek interbody device fractured during insertion into the lumbar disc space.Another implant was used to complete the procedure.No patient complications were reported.

• Brand Name: ZEUS
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): AMENDIA; marietta GA
• Manufacturer Contact: 1755 west oak parkway; marietta, GA 30062 ; 7705755200
• MDR Report Key: 3963661
• MDR Text Key: 4625594
• Report Number: 1067095-2014-00001
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2015
• Device Catalogue Number: 5-100928
• Device Lot Number: 11244
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/27/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2011
• 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 Age: 65 YR