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

Model Number 1134.0010

Device Problems Break (1069); Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Date 09/27/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a revision surgery was completed due to a rod breakage post operatively, and observed that a creo mis locking cap was found loosened at s1-s2.This event occurred in (b)(6).

• 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: 12683608
• MDR Text Key: 281129024
• Report Number: 3004142400-2021-00201
• 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: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1134.0010
• Device Lot Number: BAX792YC
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/01/2021
• Initial Date FDA Received: 10/22/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/24/2020
• 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 Race: Asian