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

Model Number 1134.0010

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 02/02/2022

Event Type  malfunction  

Event Description

It was reported that a revision was completed for (4) creo mis locking caps loosening at l5 post operatively.This event occurred in (b)(6).

Manufacturer Narrative

Post-operative imaging was returned and a single loose locking cap was observed.Evaluation of the returned devices show wear markings on the bottom of each locking cap.This observation indicates loading likely occurred primarily around the cap outer region which would suggest that those screw heads had not normalized to the rod.This may have contributed to the reported loosening; however, an exact cause could not be determined.

• 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: 13741675
• MDR Text Key: 290308939
• Report Number: 3004142400-2022-00036
• 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: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2022
• 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: BAY177BC/BAX786AC/BAY079MC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2022
• Date Manufacturer Received: 02/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2021
• 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