MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO MIS; .F:-. MIS MODULAR POLYAXIAL TULIP, 10MM REDUCTION

Model Number	1134.0110
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.Damage sustained during the implant removal render any other functional, physically, or observable analysis indeterminate.Imaging provided shows the screws were placed into the disc space.It's possible that this contributed to the reported issue; however, an exact cause cannot be determined.
Event or Problem Description
It was reported that post-operative ct scans showed a creo screw head and saddle had disassociated from the screw shank.A revision was needed to remove and replace the construct.

• Brand Name: CREO MIS
• Common Device Name: .F:-. MIS MODULAR POLYAXIAL TULIP, 10MM REDUCTION
• 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: 18825949
• Report Number: 3004142400-2018-00038
• Device Sequence Number: 11532052
• Product Code: MNH
• UDI-Device Identifier: 00889095071153
• UDI-Public: 00889095071153
• 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: 2018
• Device Explanted Year: 2018
• 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): 03/03/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1134.0110
• Device Lot Number: BAV109LD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2018
• Initial Report FDA Received Date: 03/04/2024
• 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 Sex: Unknown
• Patient Race: Asian