MAUDE Adverse Event Report: OSTEOCENTRIC TECHNOLOGIES, INC. OSTEOCENTRIC 4.0 X 44MM LOCKING BONE SCREW FASTENER ST; 4.0MM LOCKING SCREW FASTENER SELF TAPPING

Model Number	340-6044
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.A manufacturing record evaluation was performed for the finished device and no nonconformances / manufacturing irregularities were identified during the manufacturing process.
Event or Problem Description
Prox hum 4.0 locking fastener was observed to be backing out of the prox hum plate in a 79 year old female.The patient waited 4 weeks prior to seeking medical attention.The physician stated that the bone was compromised.The prox hum plate was removed and replaced with a longer compression plate and bone graft material.
Additional Manufacturer Narrative
Udi related data quality updates, product information update, & initial reporter updates: this follow-up report includes the addition of the brand name, model number, and full udi, which were missing from the initial report.The lot # and manufacturing date are on device labels, but are not on the labels as a pi.This report specifies that this is not a combination product.This report updates the initial reporter information to the physician who initially reported the issue.

• Brand Name: OSTEOCENTRIC 4.0 X 44MM LOCKING BONE SCREW FASTENER ST
• Common Device Name: 4.0MM LOCKING SCREW FASTENER SELF TAPPING
• 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: 18288436
• Report Number: 3011656326-2023-00009
• Device Sequence Number: 20507468
• Product Code: HWC
• UDI-Device Identifier: 00816950027505
• UDI-Public: (01)00816950027505
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K190430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• 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: 340-6044
• Device Catalogue Number: 340-6044
• 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: 08/11/2022
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Sex: Female