MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CALIBER EXPANDING TLIF SYSTEM; CALIBER SPACER 10 X 26MM, 9-13MM, 12° LORDOTIC

Model Number	194.611
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
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 deformation present on the disassembled endplate.Based on the imaging provided, it does not appear that the implant was fully collapsed or disassembled prior removal.This in conjunction with the possibility that the implant experienced excessive forces during removal could have resulted in the dissambly of the endplate.However, an exact cause of the reported issue could not be determined.
Event or Problem Description
It was reported there was a revision surgery to remove a caliber spacer and during removal the implant broke in half.This event occurred in australia.
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The device was returned for evaluation.Initial observation shows deformation present on the disassembled endplate.Based on the imaging provided, it does not appear that the implant was fully collapsed or disassembled prior removal.This in conjunction with the possibility that the implant experienced excessive forces during removal could have resulted in the dissambly of the endplate.However, an exact cause of the reported issue could not be determined.
Event or Problem Description
It was reported there was a revision surgery to remove a caliber spacer and during removal the implant broke in half.This event occurred in australia.

• Brand Name: CALIBER EXPANDING TLIF SYSTEM
• Common Device Name: CALIBER SPACER 10 X 26MM, 9-13MM, 12° LORDOTIC
• 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: 18834233
• Report Number: 3004142400-2023-00065
• Device Sequence Number: 7214854
• Product Code: MAX
• UDI-Device Identifier: 00889095187915
• UDI-Public: 00889095187915
• 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 Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2024

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: 194.611
• Device Lot Number: BAV053PD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2022
• Supplement Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2018
• 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