MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CALIBER; CALL BER SPACER 12 X 30MM, 11-15MM, 15°

Model Number 594.830

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 07/08/2019

Event Type  malfunction  

Event Description

It was reported that the caliber spacer collapsed post-operatively requiring revision surgery.

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.Neither the device or any imaging were available for evaluation.No determinations can be made as to the cause of the reported issue.

• Brand Name: CALIBER
• Type of Device: CALL BER SPACER 12 X 30MM, 11-15MM, 15°
• 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: 18810681
• MDR Text Key: 336625269
• Report Number: 3004142400-2019-00055
• Device Sequence Number: 1
• Product Code: MAX
• 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
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 594.830
• Device Lot Number: BAU677TH
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2017
• 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: 80 YR
• Patient Sex: Female