MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO 5.5 LOCKING CAP

Model Number	1119.0000
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/13/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a creo locking cap dislodged from the screw post-operatively requiring revision surgery.The surgeon indicated during revision that both sides of the construct were loose.
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.Upon evaluation, all of the locking caps were found to be intact.The returned locking caps, rods, and tulips did not have any catastrophic wear, fractures, or deformations.The reported issue is consistent with excessive lateral forces splaying the tulip.However.The exact cause of the reported issue cannot be determined.The following sections have been updated for this supplemental report: b4, e1, h2, h6, h10.

• Brand Name: CREO
• Common Device Name: CREO 5.5 LOCKING CAP
• 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: 18810830
• Report Number: 3004142400-2019-00063
• Device Sequence Number: 3338802
• Product Code: MNH
• UDI-Device Identifier: 00889095059489
• UDI-Public: 00889095059489
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/29/2024

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: 1119.0000
• Device Lot Number: BAW423EC
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2019
• Initial Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2019
• 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: 61 YR
• Patient Sex: Male