MAUDE Adverse Event Report: GLOBUS MEDICAL, INC.; RETENTION ROD, 6.5MM LOCKING SCREW, FOR POWER

Model Number	6190.0058
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	03/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not available for evaluation.It was reported that the threads at the tip of the retention rod fractured during surgery, leaving a portion of the retention rod threads within the head of the screw in the patient.The retention rod tip could not be returned as it remains in the patient, the other half of the retention rod was requested, but not returned for evaluation.No excessive force or misuse of the retention rod was indicated during this case.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that during a surgery the threads of a retention rod broke off and remain in the screw post operatively.

• Common Device Name: RETENTION ROD, 6.5MM LOCKING SCREW, FOR POWER
• 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: 19203686
• Report Number: 3004142400-2024-00075
• Device Sequence Number: 7927428
• Product Code: LXH
• UDI-Device Identifier: 00889095845327
• UDI-Public: 00889095845327
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: D154976
• 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): 04/26/2024

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: 6190.0058
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 04/29/2024
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 67 KG
• Patient Race: White