MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. ANTHEM; LOCKING SCREW, 2.5X14MM, COCR

Model Number	7171.5514
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was available for evaluation.After inspection, it was determined that the screw head threads are not properly manufactured.Threads are missing at the top of the head of the screw, which matches with the report that the screw passed through the plate (2171.1414) but no damage to the plate was caused or observed, as another screw was pulled and locked into the plate with no issues.The screw head failed inspection for head threads not falling within the lines indicated.The cause is traced to manufacturing.
Event or Problem Description
It was reported that an anthem locking screw was misplaced intra-operatively, and then removed and replaced in the patient.

• Brand Name: ANTHEM
• Common Device Name: LOCKING SCREW, 2.5X14MM, COCR
• 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: 19446536
• Report Number: 3004142400-2024-00103
• Device Sequence Number: 3214692
• Product Code: HWC
• UDI-Device Identifier: 00889095411317
• UDI-Public: 00889095411317
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K163361
• 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): 05/29/2024

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: 7171.5514
• Device Lot Number: BAC0A2WF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2024
• Initial Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2024
• 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: Unknown