MAUDE Adverse Event Report: OSTEOCENTRIC TECHNOLOGIES, INC. 8.0 X 180MM CANN SCREW FASTENER FULL THD

Model Number	380-5180-001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2025
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 review of the manufacturing records for the finished device found no nonconformances or manufacturing irregularities that could have contributed to this issue.
Event or Problem Description
During a left pelvis surgery, a 5.0 mm reamer was used, followed by an 8.0 mm reamer.A 8.0 x 180 mm fully threaded cannulated screw fastener was then inserted.As the fastener was being seated into the bone, the head of the fastener detached.The detached head was removed.A 8.0mm nut was put on the end of the screw to prevent migration.

• Brand Name: 8.0 X 180MM CANN SCREW FASTENER FULL THD
• Common Device Name: 8.0 X 180MM CANN SCREW FASTENER FULL THD
• 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
• Manufacturer Contact: todd evans ; 75 w 300 n; suite 150; logan 84321 ; 4357572253
• MDR Report Key: 23086429
• Report Number: 3011656326-2025-00003
• Device Sequence Number: 10516375
• Product Code: HWC
• UDI-Device Identifier: 00810074306751
• UDI-Public: (01)00810074306751(11)230721(10)EDN014
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K211290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 09/18/2025

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: 380-5180-001
• Device Catalogue Number: 380-5180-001
• Device Lot Number: EDN014
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2023
• 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: 77 YR
• Patient Sex: Male