MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. ELSA; ELSA SPACER 20 X 50MM, 8-17MM, 5-20°

Model Number	1122.1050
Medical Device Problem Code	Inadequate User Interface (2958)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The device was not available for evaluation as it remains in the patient.The implant did not show any signs of damage when attaching it to the inserter and during implantation.It is possible that misuse of the device or abuse may have caused damage t the implant that was not visible.However, the exact cause of the reported issue could not be determined.
Event or Problem Description
It was reported that post-operatively the elsa cage lost expansion.

• Brand Name: ELSA
• Common Device Name: ELSA SPACER 20 X 50MM, 8-17MM, 5-20°
• 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: 18816751
• Report Number: 3004142400-2020-00080
• Device Sequence Number: 20909940
• Product Code: OVD
• UDI-Device Identifier: 00889095334425
• UDI-Public: 00889095334425
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K161379
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1122.1050
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/20/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown