MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO DLX POLYAXIAL SCREW, 8.5X100MM

Model Number	5156.1800
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that (2) creo dlx polyaxial screws were found broken bilaterally post operatively.
Additional Manufacturer Narrative
The device was not available for evaluation as it remains in the patient.The imaging provided shows there was a lot of hardware attempting to fuse the spine; including the multiple rise interbody spacers, a total corpectomy spacer, and multiple rods.The imaging appears to show a collapsed spacer between l3/l4.If this spacer had collapsed, this can put extra force on the base of the spine/construct which may have caused the screws of s1 to fracture at the shank.However, an exact cause of the reported issue could not be determined.

• Brand Name: CREO
• Common Device Name: CREO DLX POLYAXIAL SCREW, 8.5X100MM
• 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: 15542147
• Report Number: 3004142400-2022-00143
• Device Sequence Number: 17551592
• Product Code: NKB
• UDI-Device Identifier: 00889095789072
• UDI-Public: 00889095789072
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K182375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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
• Report Date (Section B): 09/29/2022

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: 5156.1800
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Sex: Female