MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. REVERE; 9.0MM REVERE PEDICLE SCREW, 50MM

Model Number	124.096
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Subcutaneous Nodule (4548)
Date of Event	02/25/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the revere pedicle screw became loose within the patient's bone post-operatively.
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.Neither the device or any imaging could be provided for evaluation.The exact cause of the reported issue could not b determined.The following sections have been updated for this supplemental report: b4, e1, h2, h6, h10.

• Brand Name: REVERE
• Common Device Name: 9.0MM REVERE 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: 18826717
• Report Number: 3004142400-2020-00062
• Device Sequence Number: 11524864
• Product Code: MNH
• UDI-Device Identifier: 00889095037692
• UDI-Public: 00889095037692
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K091782
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• 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: 124.096
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2020
• Initial Report FDA Received Date: 03/04/2024
• 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 Sex: Female
• Patient Weight: 73 KG