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

Model Number 1134.0010

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 10/07/2021

Event Type  malfunction  

Event Description

It was reported that a revision surgery was completed to replace the loose locking cap at l2 iliac.This event occurred in (b)(6).

Manufacturer Narrative

Neither the device or any imaging could be provided for evaluation.No determinations can be made as to the cause of the reported issue.

• Brand Name: CREO MIS STABILIZATION SYSTEM
• 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: 12799858
• MDR Text Key: 284986098
• Report Number: 3004142400-2021-00217
• 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: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2021
• 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?: No
• Date Manufacturer Received: 10/15/2021
• 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
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian