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

Model Number	594.226
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	01/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient is status post an l4-5 interbody fusion for spondylolisthesis and stenosis on day one.Post operative imaging on after two days showed good hardware placement.9-days post operative check, with no complaints and good reported recovery.Who presented at 6 week post operative check with severe left-sided radiculopathy starting 2 weeks prior and noted to have a dorsal extrusion of the interbody cage at l4-5 with significant lateral recess stenosis.The patient required revision of the interbody cage and the arthrodesis and replacement of the cage with a titanium expandable cage.

• 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
• MDR Report Key: 14944193
• Report Number: 14944193
• Device Sequence Number: 14591912
• Product Code: MAX
• UDI-Device Identifier: 00849044020809
• UDI-Public: 00849044020809
• 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: 594.226
• Device Lot Number: BAM175AC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• 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: 71 KG
• Patient Race: White
• Date Report Sent to FDA: 07/06/2022