MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO FENESTRATED SCREW SYSTEM; CREO FENESTRATED, LOCKING CAP, THREADED

Model Number	1192.0010
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not available for evaluation as it was discarded by the hospital.The imaging provided shows that the left l2 locking cap had loosened and dissociated from the left l2 pedicle screw resulting in the rod dissociating from the left l2 pedicle screw.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported there was a revision surgery due to a creo fenestrated locking caps that was loose 8 months post operatively causing patient pain and subsequent rod migration.

• Brand Name: CREO FENESTRATED SCREW SYSTEM
• Common Device Name: CREO FENESTRATED, LOCKING CAP, THREADED
• 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: 15413422
• Report Number: 3004142400-2022-00135
• Device Sequence Number: 17828730
• Product Code: NKB
• UDI-Device Identifier: 00889095541656
• UDI-Public: 00889095541656
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K172269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2022

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: 1192.0010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2022
• Initial Report FDA Received Date: 09/13/2022
• 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 Age: 85 YR
• Patient Sex: Female