MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO MIS 5.5MM CURVED ROD, COBALT CHROME, 75MM LENGTH

Model Number	7134.7075
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device or any imaging was available for evaluation.No determinations can be made as to the cause of the reported issue.
Event or Problem Description
It was reported that a revision surgery was done to remove and replace a rod which had migrated post-operatively.

• Brand Name: CREO
• Common Device Name: CREO MIS 5.5MM CURVED ROD, COBALT CHROME, 75MM LENGTH
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• MDR Report Key: 11096624
• Report Number: 3004142400-2020-00183
• Device Sequence Number: 14558432
• Product Code: MNH
• UDI-Device Identifier: 00889095200461
• UDI-Public: 00889095200461
• Combination Product (Y/N): N
• 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): 12/29/2020

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: 7134.7075
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 12/30/2020
• 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: 29 YR
• Patient Weight: 120