MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. PROVIDENCE ANTERIOR CERVICAL PLATE SYSTEM; TEMPORARY FIXATION PIN

Model Number	650.010
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a providence temporary fixation pin remains in the body of c5 in the patient post operatively.This event occurred in japan.
Additional Manufacturer Narrative
Neither the device or any imaging could be provided for evaluation.No determinations could be made as to the cause of the reported issue.

• Brand Name: PROVIDENCE ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: TEMPORARY FIXATION PIN
• 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: 15105048
• Report Number: 3004142400-2022-00111
• Device Sequence Number: 4150150
• Product Code: LXH
• UDI-Device Identifier: 00849044047493
• UDI-Public: 00849044047493
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 07/12/2022

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: 650.010
• Device Lot Number: AXW168AE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown