MAUDE Adverse Event Report: AURORA SPINE LLC ECHO XL OLIF INTERBODY SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT

Model Number 108-82612-0407

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

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

Event Date 11/07/2018

Event Type  malfunction  

Manufacturer Narrative

Evaluation concluded that the surgeon likely did not distract enough space to accommodate the implant size.Due to the small opening, it is likely that the cage could not easily be inserted and thus, an excessive amount of force was used to try to force the cage into the disc space.Upon impaction, the cage cracked and broke into multiple pieces after several impactions.The damage to the echo cage appears to be due to surgeon error.The surgeon removed the broken cage and was able to insert an identical cage without issue, suggesting he was able to adequately distract the disc space and properly insert the second implant according to the surgical technique guide.The customer complaint log was reviewed for any similar occurrences--no similar complaints found.The surgeons' cases will continued to be monitored for similar issues.Investigation concluded that no further action is required at this time.

Event Description

7mm echo xl cage (p/n 108-82612-0407) fractured upon impaction.A five minute delay in surgery was reported to retrieve the broken implant.A new implant with the same lot number was inserted without issue.

• Brand Name: ECHO XL OLIF INTERBODY SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT
• Manufacturer (Section D): AURORA SPINE LLC; 1930 palomar point way; suite #103; carlsbad CA 92008
• Manufacturer Contact: laura mullens ; 1930 palomar point way; suite 103; carlsbad,, CA 92008 ; 7605292468
• MDR Report Key: 8106130
• MDR Text Key: 129063563
• Report Number: 3010326971-2018-00001
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133967
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2019
• Device Model Number: 108-82612-0407
• Device Catalogue Number: 108-82612-0407
• Device Lot Number: 1177-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Date Manufacturer Received: 11/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• 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: 48 YR
• Patient Weight: 88