MAUDE Adverse Event Report: OSTEOCENTRIC TECHNOLOGIES, INC. 4.0 X 40MM SCREW SUPER FASTENER, ST; 4.0MM X 40MM FASTENER

Model Number	340-2040
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A prox hum fastener backed out of the patient and the plate.The original surgery occured on (b)(6) 2021.The patient had healed and the fastener was removed.
Additional Manufacturer Narrative
Udi releated data quality updates, product information update, initial reporter updates, & report source update: this follow-up report includes the addition of the brand name, model number, and full udi, which were missing from the initial report.Additionally, this report updates the initial reporter information to the physician who initially reported the issue and includes the report source of how the issue became known by osteocentric technologies, inc.

• Brand Name: 4.0 X 40MM SCREW SUPER FASTENER, ST
• Common Device Name: 4.0MM X 40MM FASTENER
• Manufacturer (Section D): OSTEOCENTRIC TECHNOLOGIES, INC.; 75 w 300 n; suite 150; logan UT 84321
• Manufacturer (Section G): OSTEOCENTRIC TECHNOLOGIES, INC.; 75 w 300 n; suite 150; logan UT 84321
• MDR Report Key: 18288423
• Report Number: 3011656326-2023-00004
• Device Sequence Number: 15127430
• Product Code: HWC
• UDI-Device Identifier: 00810074300148
• UDI-Public: (01)00810074300148
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K150981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2023

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: 340-2040
• Device Catalogue Number: 340-2040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/07/2023
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 67 YR
• Patient Sex: Female