MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. ELSA-ATP; INSERTER, ANGLED, DOWN, EXPANDABLE

Model Number 6154.3001

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Neither the device or any imaging could be provided for evaluation.No determinations can be made as to the cause of the reported issue.

Event Description

It was reported that an implant was removed intra-operatively due to the inability to detach the inserter.During removal, the vertebral body was damaged.There are no plans for a revision surgery.This event occurred in germany.

Manufacturer Narrative

The device was returned for evaluation.Visual observations shows that the tip is severely bent which can be seen when the gold wheel of the inserter is rotated.The device was most likely damaged during excessive force or misuse/abuse during insertion, as it is noticeable that the tip is bent when attaching an implant.However, an exact cause of the reported issue could not be determined.The following sections have been updated: a2, a3, a4, b4, d6a, d9, g6, h2, h3, h4, h6, h10.

Event Description

It was reported that an implant was removed intra-operatively due to the inability to detach the inserter.During removal, the vertebral body was damaged.There are no plans for a revision surgery.This event occurred in germany.

• Brand Name: ELSA-ATP
• Type of Device: INSERTER, ANGLED, DOWN, EXPANDABLE
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon, PA 19403 ; 6109301800
• MDR Report Key: 13942430
• MDR Text Key: 298056008
• Report Number: 3004142400-2022-00050
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6154.3001
• Device Lot Number: DIW261AB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 68 KG