MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO ADDITION MIS REVISION FIXATION; OPEN-CLOSED LATERAL CONNECTOR, 4.75 TO 4.75, 2 SET SCREWS, 10MM WIDE

Model Number	1175.4422
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a revision surgery was needed to remove a creo addition connector that had broken and was causing patient pain post operatively.
Additional Manufacturer Narrative
A lateral connector was returned for evaluation along with a broken rod and set screws.Initial observation shows that the open rod connector lip and the rod were both broken.Both set screws were returned in the unlocked position.The open rod side set screw had deformation from the rod.Additional information provided that there was a nonunion, possibly resulting in the open connector lip to fracture.Further evaluation of the lateral connector revealed that the open rod side of the connector experienced unusual wear which is most likely caused from bending of the rod.It is possible that the rod experienced excessive bending causing the lip to fracture; however, an exact cause of the reported issue could not be determined.

• Brand Name: CREO ADDITION MIS REVISION FIXATION
• Common Device Name: OPEN-CLOSED LATERAL CONNECTOR, 4.75 TO 4.75, 2 SET SCREWS, 10MM WIDE
• 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: 15292076
• Report Number: 3004142400-2022-00129
• Device Sequence Number: 20659868
• Product Code: NKB
• UDI-Device Identifier: 00889095483048
• UDI-Public: 00889095483048
• 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 Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 08/18/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1175.4422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 08/25/2022
• 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: Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female