MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO ADDITION MIS REVISION FIXATION; DOUBLE HEAD IN-LINE CONNECTOR, 5.5-6.0 TO 5.5-6.0

Model Number	1175.9913
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The device was not available for evaluation as it was discarded by the hospital.The imaging provided shows a large gap (~5.9mm) on the left side double head in-line connector between the end of the rod and the central wall of the connector on the inferior side, indicating that the rod has slipped in the connector.No determinations could be made as to the cause of the reported issue.The following sections have been updated: b4, e1, h2, h6, h10.
Event or Problem Description
It was reported that a during a revision surgery a double head in-line connector has been found loose post operatively.

• Brand Name: CREO ADDITION MIS REVISION FIXATION
• Common Device Name: DOUBLE HEAD IN-LINE CONNECTOR, 5.5-6.0 TO 5.5-6.0
• 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: 18837354
• Report Number: 3004142400-2023-00089
• Device Sequence Number: 18006841
• Product Code: NKB
• UDI-Device Identifier: 00889095483994
• UDI-Public: 00889095483994
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K180210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• 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): 03/02/2024

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: 1175.9913
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 03/05/2024
• 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: Other
• Patient Sex: Unknown