MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO MIS; CREO MIS LOCKING CAP

Model Number 1134.0010

Device Problem Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 12/02/2021

Event Type  malfunction  

Manufacturer Narrative

Two creo mis screw heads and three locking caps were returned for evaluation.Visual inspection shows significant wear on the bottom of the two locking caps.The l5 screw head also shows signs of what appear to be marks made by high speed burr on the outer diameter.The wear pattern on the bottom of the two of the locking caps is confined to the outside edge.This type of wear pattern could indicate that the cap underwent edge loading during tightening.This could occur if the cap was prevented from being able to normalize to the rod during tightening.However, the exact cause of the reported issue could not be determined.

Event Description

It was reported that a revision was completed for creo mis locking caps (2) that had migrated post operatively.

• Brand Name: CREO MIS
• Type of Device: CREO MIS LOCKING CAP
• 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: 13095225
• MDR Text Key: 287526719
• Report Number: 3004142400-2021-00237
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 00889095071139
• UDI-Public: 00889095071139
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: D201515
• 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: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1134.0010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2021
• Date Manufacturer Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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