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

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Spinal Cord Injury (2432)
Date of Event	10/11/2018
Type of Reportable Event	Death
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3004142400-2018-00052
• Device Sequence Number: 2970405
• Product Code: MNH
• UDI-Device Identifier: 00889095071146
• UDI-Public: 00889095071146
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K124058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2018
• Initial Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 136 KG
• Patient Race: White