MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO AMP® 4.5 X 30MM MODULAR SCREW

Model Number	1067.1330
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	01/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The screw was returned for evaluation with a fracture approximately 10mm below the neck of the screw head.All applicable dimensions of the screw were measured and determined to be within specification.Constructs are most prone to failure in the l5-s1 region due to the high loads at this level.It is possible the small diameter screw used at this level, in combination with any number of unknown factors, may have contributed to the reported issue.However, an exact cause cannot be determined.
Event or Problem Description
It was reported that a patient presented six weeks post-operatively with back pain.Images taken of the patient's lumbar spine revealed a creo screw had broken near the tulip interface at the right l5 pedicle.

• Brand Name: CREO
• Common Device Name: CREO AMP® 4.5 X 30MM MODULAR 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: 18832887
• Report Number: 3004142400-2019-00006
• Device Sequence Number: 7458119
• Product Code: MNH
• UDI-Device Identifier: 00889095015348
• UDI-Public: 00889095015348
• 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 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): 03/04/2024

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: 1067.1330
• Device Lot Number: BAN255CA
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2012
• 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: 74 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic