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

Model Number	5119.6645
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation and visual observation found damage to the top edges of the t25 drive feature on the screw.There is also a rod impression on the high part of the saddle.The screw and screw head are disassembled with the saddle in the down position.Possible causes include not properly rotationally aligning the driver with the screw shank causing excessive axial force on the screw shank forcing it to disassemble, not properly axially aligning the screw shank and instrument causing the distal tip of the rigid screwdriver to apply excessive force along the top of the screw shank while attempting to thread the screw head onto the driver, and not properly seating the screw shank into the screw head prior to locking the saddle.However, the exact cause of the reported issue could not be determined.
Event or Problem Description
It was reported that screw head dissociated from the screw intra-operatively.The screw was removed and replaced.

• Brand Name: CREO
• Common Device Name: CREO THREADED 6.5X45MM REDUCTION SCREW
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• MDR Report Key: 10603144
• Report Number: 3004142400-2020-00115
• Device Sequence Number: 11696186
• Product Code: MNH
• UDI-Device Identifier: 00889095120592
• UDI-Public: 00889095120592
• 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: 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): 09/18/2020

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: JNX003KJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 09/29/2020
• 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