MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. TRANSITION; TRANSITION 6.5MM HA POLYAXIAL PEDICLE SCREW, 50MM

Model Number	152.466S
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a revision surgery was needed to replace transition screws that were found loose post-operatively.This event occurred in switzerland.
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.A single 2-level buildable transition construct was returned for evaluation.Initial inspection revealed that the 2-level buildable construct was fully assembled with one transition set screw end, 152.210, 2 transition round spool, straight, 152.206, and one transition end spool with cord, lordosed, 152.090.No findings were available at this time.

• Brand Name: TRANSITION
• Common Device Name: TRANSITION 6.5MM HA POLYAXIAL PEDICLE SCREW, 50MM
• 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: 18838073
• Report Number: 3004142400-2023-00143
• Device Sequence Number: 15324987
• Product Code: NQP
• UDI-Device Identifier: 00849044009170
• UDI-Public: 00849044009170
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K073439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 03/01/2024

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: 152.466S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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