MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO PREFERRED ANGLE SCREW, 10.5-9.0X95MM, CANNULATED, DOD, COCR HEAD, TI SHANK

Model Number	7218.7195
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was available for evaluation.Two creo preferred angle screw, 10.5-9.0x95mm, cannulated, dod, cocr head, ti shank implant were returned.Based on the provided imaging, the implants appear to be normal.The cause for the migration is unknown and no determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that a revision was needed to replace to creo preferred angle screws that backed out of the patient post operatively.

• Brand Name: CREO
• Common Device Name: CREO PREFERRED ANGLE SCREW, 10.5-9.0X95MM, CANNULATED, DOD, COCR HEAD, TI SHANK
• 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: 19650150
• Report Number: 3004142400-2024-00124
• Device Sequence Number: 6624949
• Product Code: NKB
• UDI-Device Identifier: 00193982064181
• UDI-Public: 00193982064181
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K191835
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 07/01/2024

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: 7218.7195
• Device Lot Number: BAW657UB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2019
• 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: 19 YR
• Patient Sex: Female