MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. ELSA; ELSA SPACER 20 X 65MM, 8-17MM, 5-20°

Model Number	1122.1065
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	12/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was available for evaluation.One elsa implant was returned due to migration of the implant postoperatively.The spacer was used in a single level llif to treat disc degeneration of the l3/l4 level (dos: (b)(6) 2019).The spacer was expanded to 11mm, and supplemented with 2 bone screws (5.5x50mm screw in l3, 5.5x45mm screw in l4).Post-op images of this procedure were not available for review.The patient had previous hardware in the l4/l5 and l5/s1 levels.In 2023, the patient reported acute pain.The provided follow-up imaging showed that the elsa construct had laterally migrated out of the l3/l4 disc space, and had fused in that position.It could not be established if the cage had collapsed.Revision surgery was completed to explant the spacer (dos (b)(6) 2023).Upon removal of the implant, the top and bottom endplates of the device disassembled from the ramps.Initial observation of the spacer showed that the tracks on the superior endplate were severely damaged, and were unable to interface with the front ramp.Additionally, the drive screw, front ramp, and back ramp all had scratches through the anodization layer, and other signs of damage.It is likely the implant disassembly was due to this damage the implant experienced while removing it from the fused l3/l4 level, however no determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that a revision was needed due to an elsa spacer migration post operatively, causing patient pain.This event occurred in australia.

• Brand Name: ELSA
• Common Device Name: ELSA SPACER 20 X 65MM, 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: 19097396
• Report Number: 3004142400-2024-00064
• Device Sequence Number: 7408031
• Product Code: OVD
• UDI-Device Identifier: 00889095334456
• UDI-Public: 00889095334456
• 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: 2019
• 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): 04/12/2024

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: 1122.1065
• Device Lot Number: BAV210RF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2018
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Age: 63 YR
• Patient Sex: Male
• Patient Race: White