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

Model Number 1134.0010

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

The device could not be returned for evaluation as it remains in the patient.The imaging provided shows the l4 left locking cap is loosened.Since the bone fusion was completed, a revision surgery is not scheduled at this time and the implant will remain in the patient.No determinations could be made as to the cause of the reported issue.

Event Description

It was reported there is a creo mis locking cap that is loose post-operatively.There are no current plans for revision.This event occurred in japan.

• 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 ; 6109301800
• MDR Report Key: 14604583
• MDR Text Key: 300467876
• Report Number: 3004142400-2022-00088
• 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: K124058
• 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: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• 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?: No
• Date Manufacturer Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 60 YR
• Patient Sex: Female
• Patient Race: Asian