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

Model Number	1119.7055
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.It was reported a creo rod became loose post-operatively.From the x-ray images the observed failure is consistent with destabilizing the construct by removing the novel interbody spacer and replacing it with the patients bone.The improperly installed cross connector and the unstable construct at l4/l5 is consisten with a destabilized construct imaparting in excessive torsional forces on the construct resulting in the dissociation of the rod from the screw.
Event or Problem Description
It was reported that a creo rod became loose post-operatively.

• Brand Name: CREO
• Common Device Name: 5.5 MM CURVED ROD, TITANIUM ALLOY, 55MM LENGTH
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon, PA 19403 ; 6109301800
• MDR Report Key: 18823387
• Report Number: 3004142400-2020-00022
• Device Sequence Number: 20636684
• Product Code: MNH
• UDI-Device Identifier: 00889095064742
• UDI-Public: 00889095064742
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K124058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• 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): 03/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1119.7055
• Device Lot Number: BGV215EF
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 03/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR
• Patient Sex: Unknown