MAUDE Adverse Event Report: OSTEOCENTRIC TECHNOLOGIES, INC. 13 X 90MM LAG FASTENER

Model Number	324-13090
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was conducted which included review of applicable production records and dimensional evaluation of returned components.The reported device malfunction was confirmed.No manufacturing nonconformances or product specification deviations were identified as it relates to the reported issue.The cause of the reported breakage could not be conclusively determined based on the available information.No additional adverse patient consequences associated with the reported device malfunction were identified.
Event or Problem Description
It was reported that a patient underwent femoral neck fracture repair surgery on (b)(6) 2026.Follow-up evaluation performed between the initial surgery and (b)(6) 2026 revealed that the fracture had not healed.Revision surgery was subsequently performed on (b)(6) 2026.During the revision procedure, it was determined that one 13 x 90 mm lag fastener (part 324-13090, lot hfi042) and two 6.0 x 95 mm bone screw fasteners st (part 360-1095, lot hfv009) had broken.The date the devices broke is unknown.The 13 x 90 mm lag fastener was completely removed and recovered.The two 6.0 x 95 mm bone screw fasteners st were partially removed, with the distal tip fragments remaining implanted in the patient.No additional adverse patient consequences associated with the reported device issue were reported.

• Brand Name: 13 X 90MM LAG FASTENER
• Common Device Name: 13 X 90MM LAG 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
• Manufacturer Contact: todd evans ; 75 w 300 n; suite 150; logan, UT 84321 ; 4357572253
• MDR Report Key: 25480190
• Report Number: 3011656326-2026-00001
• Device Sequence Number: 5700588
• Product Code: JDO
• UDI-Device Identifier: 00810189110076
• UDI-Public: (01)00810189110076(10)HFI042(11)251013
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K230764
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/11/2026

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: 324-13090
• Device Catalogue Number: 324-13090
• Device Lot Number: HFI042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2025
• 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: 55 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White