MAUDE Adverse Event Report: IN2BONES, USA 5MS; LATERAL NECK PLATE

Model Number	P60 ST032
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Implant Pain (4561)
Date of Event	02/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported in a complaint that a driver broke during a plate removal case.It was later reported during the investigation that the plate removal was due to the patient having pain.A review of the device history record for the subject plate confirmed that there were no non-conformities associated with the plate.

• Brand Name: 5MS
• Common Device Name: LATERAL NECK PLATE
• Manufacturer (Section D): IN2BONES, USA; 6000 poplar avenue; suite 115; memphis TN 38119
• Manufacturer (Section G): IN2BONES, USA; 6000 poplar avenue; suite 115; memphis TN 38119
• Manufacturer Contact: robert buchanan ; 6000 poplar avenue; suite 115; memphis, TN 38119 ; 9012607931
• MDR Report Key: 21561700
• Report Number: 3011580264-2025-00001
• Device Sequence Number: 17236938
• Product Code: HRS
• UDI-Device Identifier: 00817906021523
• UDI-Public: (01)00817906021523(17)280831(10)2303556
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170518
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: P60 ST032
• Device Lot Number: 2303556
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2023
• 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 Age: 49 YR
• Patient Sex: Unknown
• Patient Weight: 141 KG