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	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a revision was performed to replace an elsa spacer 20 x 50mm, 8-17mm that was found to be migrating laterally out of the ipsilateral disc space.
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The device was available for evaluation.One elsa spacer, 20 x 50mm, 8-17mm, 5-20°, was reported to have migrated laterally out of the patient's disc space after implantation.The patient underwent additional surgery to add supplemental posterior fixation, and the elsa spacer was explanted and replaced with a rise-l spacer.Further reporting present at the case revealed that during the procedure, the surgeon had elected to not add supplemental fixation, constituting an off-label use of the device (from elsa product insert di195a: "[elsa] devices are intended for use with supplemental fixation").Upon receiving the device on (b)(6) 2024, the implant's functionality was assessed, and was determined to be fully functional as per the requirements.In the provided post-operative imaging, the bone screw appears to be constrained to the spacer body via the locking screw.The lateral migration of the spacer/bone screw construct is then attributed to the lack of supplemental fixation.No determinations could be made as to the cause of the reported issue.

• 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: 18809810
• Report Number: 3004142400-2023-00192
• Device Sequence Number: 15266002
• 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: 2023
• Device Explanted Year: 2023
• 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): 02/28/2024

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
• Device Lot Number: BAB6E9HH
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2023
• Initial Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2023
• 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