MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CALIBER; CALIBER SPACER, 12X26MM, 9-13MM

Model Number	594.426
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not available for evaluation.The imaging provided showed that the implant is no longer contained within the l3/l4 space.However, no determinations can be made as to the cause of the reported issue.
Event or Problem Description
It was reported that a revision surgery was done to replace (1) caliber spacer that moved posteriorly 1 month post operatively.
Additional Manufacturer Narrative
The device was returned for evaluation.Initial observation shows significant deformation on one of the peek endplates, the other endplate appears to be fully contracted.The implant could not be expanded due to the aforementioned peek endplate damage.Imaging provided shows the implant is not in the same position with respect to the superior and inferior vertebral bodies.There appears to be a spondylolisthesis to an unknown degree between the two effected lumbar levels.However, the exact cause of the reported issue could not be determined.
Event or Problem Description
It was reported that a revision surgery was done to replace a caliber spacer that moved posteriorly 1 month post operatively.

• Brand Name: CALIBER
• Common Device Name: CALIBER SPACER, 12X26MM, 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 ; 6109301822
• MDR Report Key: 13602854
• Report Number: 3004142400-2022-00028
• Device Sequence Number: 5289046
• Product Code: MAX
• UDI-Device Identifier: 00849044021028
• UDI-Public: 00849044021028
• 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: 2021
• 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): 03/16/2022

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: 594.426
• Device Lot Number: BAX104AH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2022
• Supplement Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 02/25/2022
• Supplement Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2020
• 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 Age: 69 YR
• Patient Sex: Male