MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. TRANSITION; TRANSITION 8.5MM MIS HA POLYAXIAL PEDICLE SCREW, 40MM

Model Number	152.784S
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The description of the event states that haloing was observed around the transition screw.Haloing is an indication of screw movement post-operatively, suggesting that fixation was compromised at this level.It's possible that this could have been caused by excessive stress, improper screw sizing, poor bone purchase, or pseudoarthrosis at that level.The screw was not returned for evaluation and the radiographic images were not available.The exact cause of the reported issue cannot be determined.
Event or Problem Description
It was reported that post-operative imaging found the ha screws placed at l4-5 were solid; however, haloing around the s1 ha screw indicated the screw was mobile.A revision surgery was performed to remove the loosened screw.

• Brand Name: TRANSITION
• Common Device Name: TRANSITION 8.5MM MIS HA POLYAXIAL PEDICLE SCREW, 40MM
• 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: 18826845
• Report Number: 3004142400-2018-00051
• Device Sequence Number: 7934899
• Product Code: NQP
• UDI-Device Identifier: 00849044084412
• UDI-Public: 00849044084412
• 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 Explanted Year: 2018
• 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): 03/04/2024

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
• Operator of Device: Health Professional
• Device Model Number: 152.784S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2018
• Initial Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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