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

Model Number 1134.0010

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 06/10/2020

Event Type  malfunction  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.The devices were not returned for evaluation as they were discarded by the hospital.Ct imaging was provided showing a t10- llllum construct with locking caps out of the screw heads at t1o and t11.The previous revisions indicate that significantflexion forces may have been present at the levels where the locking caps backed out.Addi tionally, breaking the tabs off of the screw head using the incorrect tequnique may have placed additional forces on the device, reducing the strength of the interconnection however , an exact cause of the reported issue could not be determined.The following sections have been updated for this supplemental report: b4, e1, g6, h2, h6, h10.

Event Description

It was reported that five creo mis locking caps were found loosened approximately six months post-operatively.

• 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: 18827081
• MDR Text Key: 336788806
• Report Number: 3004142400-2020-00064
• 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: 03/04/2024

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
• Initial Date Manufacturer Received: 06/12/2020
• Initial Date FDA Received: 03/04/2024
• 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): Other
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Race: White