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

Model Number 1192.0020

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

The device was not available as it remains in the patient.The immediate post-operative imaging provided showed the locking caps sitting slightly proud of the screw head.In follow up, additional post-operative images appear to show a rod slip.The exact cause of the reported issue cannot be determined.

Event Description

It was reported that a locking cap has loosened post-operatively.

• Brand Name: CREO
• Type of Device: CREO FENESTRATED, MIS LOCKING CAP
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon 19403 ; 6109301800
• MDR Report Key: 12221632
• MDR Text Key: 265353482
• Report Number: 3004142400-2021-00132
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: D319117
• 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: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1192.0020
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/24/2021
• Was Device Evaluated by Manufacturer?: No
• 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