MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO MIS 5.5MM CURVED ROD, TITANIUM ALLOY, 50MM LENGTH

Model Number	1134.7050
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned devices showed the screw heads to display extreme amounts of wear on exterior surfaces.The location of the damage observed indicates that the wear is very likely the result of the implant removal.The wear patterns on the rods show evidence of sliding; however, it cannot be determined if this occurred while implanted or during removal.The locking caps show areas of stripped anodizing, and the wear pattern on the bottom surface is inconsistent.The ring pattern around the outer diameter may indicate tightening of the locking cap while the screw head is not normalized to the rod.The exact cause of the reported issue could not be determined.
Event or Problem Description
It was reported that a revision surgery was done for two creo mis rods that were loose post-operatively.

• Brand Name: CREO
• Common Device Name: CREO MIS 5.5MM CURVED ROD, TITANIUM ALLOY, 50MM LENGTH
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• MDR Report Key: 11952106
• Report Number: 3004142400-2021-00108
• Device Sequence Number: 3465243
• Product Code: MNH
• UDI-Device Identifier: 00889095072181
• UDI-Public: 00889095072181
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/02/2021

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: 1134.7050
• Device Lot Number: JNW238JC/JNW345RC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 06/07/2021
• 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