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

Model Number 594.426

Device Problem Positioning Problem (3009)

Patient Problem Insufficient Information (4580)

Event Date 01/31/2022

Event Type  malfunction  

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 Description

It was reported that a revision surgery was done to replace (1) caliber spacer that moved posteriorly 1 month post operatively.

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 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
• Type of Device: 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
• MDR Text Key: 289062829
• Report Number: 3004142400-2022-00028
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00849044021028
• UDI-Public: 00849044021028
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102293
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 594.426
• Device Lot Number: BAX104AH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Sex: Male