MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO FENESTRATED, MIS TULIP, 10MM REDUCTION

Model Number	1192.0210S
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was unavailable for evaluation.Based on the complaint information one sterile packed screw shank was assembled with a creo fenestrated screw head and placed in a patient for a multilevel fusion, and when inserting one of the screws the screw became loose and separated.Because the device was not returned for evaluation and surgical conditions could not be replicated, no determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that a creo fenestrated screw head has come loose post operatively.This event occurred in germany.

• Brand Name: CREO
• Common Device Name: CREO FENESTRATED, MIS TULIP, 10MM REDUCTION
• 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: 20354334
• Report Number: 3004142400-2024-00219
• Device Sequence Number: 14297468
• Product Code: NKB
• UDI-Device Identifier: 00889095541717
• UDI-Public: 00889095541717
• 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: 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): 10/02/2024

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: 1192.0210S
• Device Lot Number: GBC190GD
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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