MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CALIBER; CALIBER SPACER 10 X 30MM, 7MM, 0°-10°

Model Number	194.274
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not available as it remains in the patient.Imaging provided shows that the tantalum radiographic marker for the superior endplate is no longer in the disc space.The inferior radiographic marker appears to still be in the intended location.The exact cause of the reported issue could not be determined.
Event or Problem Description
It was reported that a revision was completed due to patient pain relating to a caliber cage.The cage was not removed and remains in the patient.This event occurred in (b)(6).
Additional Manufacturer Narrative
The device was not available as it remains in the patient.Imaging provided shows that the tantalum radiographic marker for the superior endplate is no longer in the disc space.The inferior radiographic marker appears to still be in the intended location.The exact cause of the reported issue could not be determined.
Event or Problem Description
It was reported that a revision was completed due to patient pain relating to a caliber cage.The cage was not removed and remains in the patient.This event occurred in australia.

• Brand Name: CALIBER
• Common Device Name: CALIBER SPACER 10 X 30MM, 7MM, 0°-10°
• 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 ; 6109301822
• MDR Report Key: 12700445
• Report Number: 3004142400-2021-00199
• Device Sequence Number: 5548261
• Product Code: MAX
• UDI-Device Identifier: 00889095187076
• UDI-Public: 00889095187076
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K123231
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 194.274
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2021
• Supplement Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 10/26/2021
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 64 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic