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

Model Number 72-00-092810-00

Device Problems Collapse (1099); Migration or Expulsion of Device (1395)

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

Event Date 02/23/2017

Event Type  malfunction  

Event Description

Implant collapse and migration; will likely require revision surgery.

• Brand Name: OMEGALIF
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): AMENDIA; 1755 west oak parkway; marietta GA 30062
• Manufacturer (Section G): AMENDIA; 1755 west oak parkway; marietta GA 30062
• Manufacturer Contact: bruce hooper ; 1755 west oak parkway; marietta, GA 30062 ; 8777553329
• MDR Report Key: 6432161
• MDR Text Key: 71098029
• Report Number: 1067095-2017-00003
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 03/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 72-00-092810-00
• Device Lot Number: 131523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2017
• 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