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

Device Problem Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.The device was not returned for evaluation.It was determined that the screw head had not detached post-operatively, but was not fully attached intra-operatively.If a screw head is able to detach from the screw shank without any reduction force, it is likely that a head inserter was not used.The head inserter must be used before any screw head is used in surgery.However, the exact cause of the reported issue could not be determined.The following sections have been updated for this supplemental report: b4, h2, h6, e1, h10.

Event Description

It was reported that the creo mis screw head detached from the screw post-operatively.

• Brand Name: CREO MIS
• Type of Device: CREO MIS SCREW
• 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: 18818326
• MDR Text Key: 336682216
• Report Number: 3004142400-2020-00078
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• 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: 07/15/2020
• 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