MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO 5.5, 6.5 X 45MM POLYAXIAL SCREW

Model Number	5119.1645
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	02/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.Evaluation of the returned devices found gouging on the inner and out diameter of the screw heads.One screw had the top part of the screw head partially sheared off at the locking cap channel.The gouging indicates that significant force was placed on the screw heads to remobilize or remove the polyaxial screws from the pedicle.The exact cause of the reported issue cannot be determined.The following sections are been updated: b4, e1, h2, h6, h10.
Event or Problem Description
It was reported that during final tightening with the torque limiting driver in a screw rod construct, the locking caps popped out and the screw head was damaged.The screw head was monoaxial at this stage as expected.In an attempt to remove the screw, the screw head needed to become polyaxial again.During this maneuver the pedicle broke.

• Brand Name: CREO
• Common Device Name: CREO 5.5, 6.5 X 45MM POLYAXIAL SCREW
• 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: 18827940
• Report Number: 3004142400-2019-00017
• Device Sequence Number: 11505937
• Product Code: MNH
• UDI-Device Identifier: 00889095104141
• UDI-Public: 00889095104141
• 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: 2019
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/04/2024

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?: No
• Device Model Number: 5119.1645
• Device Lot Number: BAV314KL,BAV820TL,BAU510VK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2019
• Initial Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2018
• 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