MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO MIS; CREO MIS 5.5MM CURVED ROD, TITANIUM ALLOY, 55MM LENGTH

Model Number	1134.7055
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device or imaging was available for evaluation.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that a revision surgery was completed to replace a creo mis rod that had slipped post operatively.

• Brand Name: CREO MIS
• Common Device Name: CREO MIS 5.5MM CURVED ROD, TITANIUM ALLOY, 55MM LENGTH
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• MDR Report Key: 12352970
• Report Number: 3004142400-2021-00159
• Device Sequence Number: 3476766
• Product Code: MNH
• UDI-Device Identifier: 00889095072198
• UDI-Public: 00889095072198
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: D201515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• 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): 08/19/2021

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: 1134.7055
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 08/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 30 YR