MAUDE Adverse Event Report: OSTEOCENTRIC TECHNOLOGIES, INC. Ø7.0 X 43MM X 85MM CANNULATED PARTIAL THREAD SCREW; 7.0 X 85MM CANN SCREW FASTENER 43MM VAR THD

Model Number	370-5085-043
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was observed that a fastener backed following surgery for sacral insufficiency fractures.This observation was made at 2.5 weeks post-op.
Additional Manufacturer Narrative
The results of the investigation is inconclusive as the device was not received for evaluation.Manufacturing and inspection records could not be reviewed as the device lot number is unknown.Based on the information received, the root cause could not be determined.
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, full udi, and 510(k) number, which were missing from the initial report.This report specifies that this is not a combination product.Additionally, this report updates the initial reporter information to the physician who initially reported the issue.

• Brand Name: Ø7.0 X 43MM X 85MM CANNULATED PARTIAL THREAD SCREW
• Common Device Name: 7.0 X 85MM CANN SCREW FASTENER 43MM VAR 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, UT 84321 ; 4357572253
• MDR Report Key: 18909332
• Report Number: 3011656326-2024-00001
• Device Sequence Number: 15146215
• Product Code: HWC
• UDI-Device Identifier: 00816950026997
• UDI-Public: (01)00816950026997
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K170021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/14/2024

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: 370-5085-043
• Device Catalogue Number: 370-5085-043
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 78 YR
• Patient Sex: Female