MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. INDEPENDENCE; BONE SCREW

Model Number	597.820
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither device or any imaging was available for evaluation.No determinations can be made at this time.
Event or Problem Description
It was reported that a revision surgery was completed due to an independence bone screw backing out post-operatively.This event occurred in the (b)(6).

• Brand Name: INDEPENDENCE
• Common Device Name: BONE SCREW
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• MDR Report Key: 12634880
• Report Number: 3004142400-2021-00197
• Device Sequence Number: 4704084
• Product Code: MNH
• UDI-Device Identifier: 00889095166903
• UDI-Public: 00889095166903
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 10/08/2021

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: 597.820
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 10/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other