MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO MIS; CREO MIS MODULAR POLYAXIAL TULIP, 30MM REDUCTION

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Spinal Cord Injury (2432)

Event Date 10/11/2018

Event Type  Death  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.Based on the reported information, it does not appear that the creo mis device directly contributed to the arrest; however, it may have been necessary to complete additional surgical steps before the patient could be repositioned supine to receive resuscitative efforts.

Event Description

The description of the event states that haloing was observed around the transition screw.Haloing is an indication of screw movement post-operatively, suggesting that fixation was compromised at this level.It's possible that this could have been caused by excessive stress, improper screw sizing, poor bone purchase, or pseudoarthrosis at that level.The screw was not returned for evaluation and the radiographic images were not available.The exact cause of the reported issue cannot be determined.

• Brand Name: CREO MIS
• Type of Device: CREO MIS MODULAR POLYAXIAL TULIP, 30MM REDUCTION
• 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: 18826911
• MDR Text Key: 336785134
• Report Number: 3004142400-2018-00052
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 00889095071146
• UDI-Public: 00889095071146
• 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: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/11/2018
• 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): Death
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 136 KG
• Patient Race: White