MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. PATRIOT; SIGNATURE IMPLANT HOLDER, SHORT

Model Number	668.101
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.Imaging provided showed a small fragment of metal in the patient on the ipsilateral side of the disc space.It can be concluded that the small fragment was one of the two stabilizing tabs on the main shaft assembly of the device.The exact cause of the reported issue could not be determined.
Event or Problem Description
It was reported that the tip of the signature implant holder broke intra-operatively and was left in the signature tps cage.No revision surgery is planned to remove the broken piece.
Additional Manufacturer Narrative
Visual inspection confirms that one of the stabilizing tabs is missing.Measurements were taken of the existing spring tab and deemed to be within specification.The exact cause of the spring tab breaking off could not be determined.
Event or Problem Description
It was reported that the tip of the signature implant holder broke intra-operatively and was left in the signature tps cage.No revision surgery is planned to remove the broken piece.

• Brand Name: PATRIOT
• Common Device Name: SIGNATURE IMPLANT HOLDER, SHORT
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• MDR Report Key: 10543601
• Report Number: 3004142400-2020-00104
• Device Sequence Number: 13770596
• Product Code: MAX
• UDI-Device Identifier: 00849044073553
• UDI-Public: 00849044073553
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072970
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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,Followup
• Report Date (Section B): 01/27/2021

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: 668.101
• Device Lot Number: FAU115AD
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/19/2020
• Supplement Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 02/01/2021
• 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
• Patient Age: 76 YR