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

Model Number	5119.1647
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection shows the screw component and clamps have dissociated from the screw head and the rest of the screw assembly.The rod remains locked in the top portion of the screw head by the locking cap.There is boney tissue lodged beneath the rod and has been forced through the center hole and around the sides of the saddle.One of the cages used was pushed out of the interverbal space.It is possible that the presence of boney tissue resulted in increased interference between the mating components.The damage shown to the screw shank could indicate that the rigid screwdriver was not properly rotationally aligned before attempting to thread the screw head; however, the exact cause of the reported issue could not be determined.
Event or Problem Description
It was reported by a representative from belgium that a revision surgery was done due to a screw which had broken 6 weeks post-operatively with loss of compression and push back of 1 of the sustain cages.

• Brand Name: CREO
• Common Device Name: CREO THREADED 6.5X45MM POLYAXIAL SCREW
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• MDR Report Key: 11362285
• Report Number: 3004142400-2021-00028
• Device Sequence Number: 20023654
• Product Code: MNH
• UDI-Device Identifier: 00889095104158
• UDI-Public: 00889095104158
• Combination Product (Y/N): N
• 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: 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): 02/17/2021

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: 5119.1647
• Device Lot Number: BAX212YH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 02/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Weight: 110