MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. PROTEX; 6.0MM STRAIGHT ROD, 300MM

Model Number	109.519
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device or any imaging could be provided for evaluation.No determinations can be made as to the cause of the reported issue.
Event or Problem Description
It was reported that a rod fracture was found 2 years post-operatively, with subsequent disassociation of the locking cap from the screw head and the rod pulling out from the screw head.

• Brand Name: PROTEX
• Common Device Name: 6.0MM STRAIGHT ROD, 300MM
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• MDR Report Key: 10655826
• Report Number: 3004142400-2020-00141
• Device Sequence Number: 14273186
• Product Code: MNH
• UDI-Device Identifier: 00889095034769
• UDI-Public: 00889095034769
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K052069
• 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): 10/06/2020

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: 109.519
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 10/09/2020
• 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