MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CALIBER EXPANDING TLIF SYSTEM; CALIBER SPACER 10 X 26MM, 9-13MM

Model Number	194.426
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The device was returned for evaluation.Initial observation shows the posterior corner removed from the endplate that is disassociated from the implant assembly as seen in the images initially provided.This appears to have been done with a burr, pituitary, kerrison or ronguer but the exact method is unknown.The second endplate is partially disassociated from the assembly along the side of the assembly.There is deformation along both sides of the endplate that is partially disassociated.It is unknown if the deformation happened during insertion or removal of the implant.There is excessive deformation on the posterior face of the frame and the drive screw where the inserter would attach.The frame also has some deformation along the sides.It is possible that excessive force during impaction caused the deformation and failure; however, the exact cause of the reported issue could not be determined.
Event or Problem Description
It was reported that a revision surgery was needed for a caliber spacer endplate that broke and migrated 3 days post operatively.

• Brand Name: CALIBER EXPANDING TLIF SYSTEM
• Common Device Name: CALIBER SPACER 10 X 26MM, 9-13MM
• 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: 18834179
• Report Number: 3004142400-2023-00058
• Device Sequence Number: 17953395
• Product Code: MAX
• UDI-Device Identifier: 00849044020298
• UDI-Public: 00849044020298
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K102293
• 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): 03/01/2024

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: 194.426
• Device Lot Number: MKX266KH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2020
• 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: Female