MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CALIBER EXPANDING TLIF SYSTEM; CALIBER SPACER, 12X26MM, 10-15MM

Model Number	594.226
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a caliber spacer migrated posteriorly six months post operatively.
Additional Manufacturer Narrative
The device was returned for evaluation.Initial observation shows the implant appears to be fully contracted.No defects or damage is visible on the implant endplates.The implant was able to be expanded without issue.Imaging provided shows that 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.It appears that the implant isn't oriented parallel to the superior and inferior vertebral endplates, which could have contributed to the reported failure.However, the exact cause of the reported issue could not be determined.

• Brand Name: CALIBER EXPANDING TLIF SYSTEM
• Common Device Name: CALIBER SPACER, 12X26MM, 10-15MM
• 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: 13942406
• Report Number: 3004142400-2022-00029
• Device Sequence Number: 4932919
• Product Code: MAX
• UDI-Device Identifier: 00849044020809
• UDI-Public: 00849044020809
• 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
• 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: 594.226
• Device Lot Number: BAM175AC
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2022
• Initial Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2011
• 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: Prefer Not To Disclose