MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO FENESTRATED, LOCKING CAP, THREADED

Model Number	1192.0010
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause of the reported issue could not yet be determined.
Event or Problem Description
It was reported by a representative from (b)(6) , that a revision surgery as done due to creo mis locking caps loosening post-operatively.
Event or Problem Description
It was reported by a representative from austria, that a revision surgery as done due to creo mis locking caps loosening post-operatively.
Additional Manufacturer Narrative
Evaluation of the subject device revealed wear markings on interconnecting surfaces, similar to those observed during normal use.Pre-op images show no use of cement and at least one loose locking cap.The exact cause of the reported issue could not be determined.

• Brand Name: CREO
• Common Device Name: CREO FENESTRATED, LOCKING CAP, THREADED
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• MDR Report Key: 11962266
• Report Number: 3004142400-2021-00110
• Device Sequence Number: 4765045
• Product Code: MNH
• UDI-Device Identifier: 00889095541656
• UDI-Public: 00889095541656
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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,Followup
• Report Date (Section B): 06/15/2021

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: 1192.0010
• Device Lot Number: BAX570JA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2021
• Initial Date Received by Manufacturer: 05/19/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 07/06/2021
• 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