MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO THREADED 6.5X45MM REDUCTION SCREW,

Model Number	5119.6645
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The device was returned for evaluation and initial observation showed a screw head disassociated from the screw shank.The implants clamps and saddle were missing and were unable to be evaluated.The exact cause of the reported issue could not be determined.
Event or Problem Description
It was reported that the right l1 screw head disassociated from the screw approximately two days post-operatively.Additionally, it was found during the revision that the left l1 screw had pulled out of the pedicle.

• Brand Name: CREO
• Common Device Name: CREO THREADED 6.5X45MM REDUCTION SCREW,
• 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: 18816833
• Report Number: 3004142400-2020-00083
• Device Sequence Number: 8308176
• Product Code: MNH
• UDI-Device Identifier: 00889095120592
• UDI-Public: 00889095120592
• 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: 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
• Report Date (Section B): 02/28/2024

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: 5119.6645
• Device Lot Number: JNX023MJ
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (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 Sex: Male