MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. HEDRON; HEDRON IA SPACER, 26X34, 15MM, 2

Model Number	1212.0915S
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was unavailable for evaluation.It was reported that a revision was performed to remove a hedron ia spacer to replace with a graft.It was stated that post-operatively, the surgeon decided the implant was placed too laterally and decided to revise.No damage or migration of the globus implants could be identified.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that a revision was performed to remove a hedron ia spacer to replace with a graft.

• Brand Name: HEDRON
• Common Device Name: HEDRON IA SPACER, 26X34, 15MM, 2
• 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: 19659297
• Report Number: 3004142400-2024-00133
• Device Sequence Number: 20519512
• Product Code: MAX
• UDI-Device Identifier: 00193982191702
• UDI-Public: 00193982191702
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K191391
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted 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): 07/02/2024

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: 1212.0915S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 07/02/2024
• 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 Age: 66 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Race: White