MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO 5.5 LOCKING CAP

Model Number	1119.0000
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device or any imaging could be provided 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 for 2 s1 locking caps that allowed for the rod to slip post-operatively.
Additional Manufacturer Narrative
The device was available for evaluation.The observed failure is consistent with error in user technique.The instability of the construct due to the rod slippage could have allowed for the rise cage to migrate out of the disc space.However, 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 2 s1 locking caps that allowed for the rod to slip post-operatively.

• Brand Name: CREO
• Common Device Name: CREO 5.5 LOCKING CAP
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• MDR Report Key: 10879452
• Report Number: 3004142400-2020-00159
• Device Sequence Number: 16872338
• Product Code: MNH
• UDI-Device Identifier: 00889095059489
• UDI-Public: 00889095059489
• 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,Followup
• Report Date (Section B): 12/16/2020

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: 1119.0000
• Device Lot Number: BAX155LD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 12/18/2020
• 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