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

Model Number	1134.0010
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The locking caps were returned for evaluation and found to pass all dimensional and functional inspections.Two creo fenesfrated mis locking caps show wear marks on the base of the implant which is consistent with rubbing between the rod and the base of the set screw during proper final tightening.One creo mis locking cap showed no wear pattern near the center, the lack of an hour glass pattern on this surface indicates the locking cap partially engaged the rod as the locking cap was tightened.Partial engagement of the locking cap could be caused by the rod or screw head being tilted at such an angle that the bottom of the locking cap does not contact the rod.This could be cause by additional tissue preventing the complete seating of the rod in the screw head.However, the exact cause of the reported issue could not be determined.The following sections have been updated for this supplemental report: b4, e1, h2, h6, h10.
Event or Problem Description
It was reported that one creo mis locking cap had been left in the patient during the initial surgery.Additionally, it was found that the right land l5 locking caps backed out of the screw head post-operatively.

• Brand Name: CREO
• Common Device Name: CREO MIS
• 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: 18827054
• Report Number: 3004142400-2020-00065
• Device Sequence Number: 20780120
• Product Code: MNH
• UDI-Device Identifier: 00889095071139
• UDI-Public: 00889095071139
• 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: 2020
• Device Explanted Year: 2020
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1134.0010
• Device Lot Number: BAX138MB
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2020
• Initial Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Other
• Patient Sex: Unknown
• Patient Race: White