MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. REFLECT SCOLIOSIS CORRECTION SYSTEM HDE; REFLECT 5.0MM CORD WITH COLLET, 350MM

Model Number	1244.1351S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not available for evaluation.Investigation revealed that there was no device malfunction.The reported complaint appears to be an adverse event without a reported device problem.The surgical technique specifies that the collet is to be removed at the conclusion of the procedure.The risk is documented and will continue to be monitored.Cause of the reported issue can be traced to user technique.
Event or Problem Description
It was reported that a revision was needed to remove the collet and excess cord from the reflect implant that was not removed during the original surgery, confirmed by post op scans.

• Brand Name: REFLECT SCOLIOSIS CORRECTION SYSTEM HDE
• Common Device Name: REFLECT 5.0MM CORD WITH COLLET, 350MM
• 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: 22099883
• Report Number: 3004142400-2025-00112
• Device Sequence Number: 18231165
• Product Code: QHP
• UDI-Device Identifier: 00193982313470
• UDI-Public: 00193982313470
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: H210002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 05/28/2025

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
• Operator of Device: Health Professional
• Device Model Number: 1244.1351S
• Device Lot Number: GBC446UB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 05/28/2025
• 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 Sex: Male
• Patient Race: White