MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CALIBER; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	594.426
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient underwent l3-4 and l4-5 transforaminal lumbar interbody arthrodesis with posterior lateral fusion and instrumentation.Post operative imaging demonstrated hardware in good placement.3 weeks post fusion, patient developed acute onset of left lower extremity radicular pain that started approximately 3 weeks ago.His imaging studies show evidence of posterior displacement of the l4-5 interbody cage and recurrent spondylolisthesis at the l4-5 level.Given the findings on the imaging studies and the patient's neurological symptoms, the plan is to perform removal of the l4-5 interbody cage, decompression of the lateral recess and spinal canal and revision of the interbody arthrodesis and placement of the interbody cage.On revision -the screw was turned in a counter- clockwise direction allowing for collapse of the cage.This provided only for collapse of the caudal portion of the l4-5 interbody cage.The rostral portion of the cage did not collapse and could be seen to be relatively deformed relative to the titanium core.

• Brand Name: CALIBER
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; valley forge business center; audubon, pa 19403 PA 19403
• MDR Report Key: 14944222
• Report Number: 14944222
• Device Sequence Number: 14631362
• Product Code: MAX
• UDI-Device Identifier: 00849044021028
• UDI-Public: 00849044021028
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/06/2022
• Report Date (Section F): 07/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 594.426
• Device Catalogue Number: 594.426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 YR
• Event Location: Other
• Date Report to Manufacturer: 07/07/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/07/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Race: White
• Date Report Sent to FDA: 07/06/2022