MAUDE Adverse Event Report: OSTEOMED, LLC 1.6MM X 8MM SCREW; SCREW, FIXATION, BONE

Model Number	208-1608
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To date, the device has not returned for evaluation, the root cause could not be established.Additional reporting on this event will be provided as a follow up report if more information becomes available.
Event or Problem Description
It was reported that the acumed sales representative had a meeting with a customer and while onsite, the customer notified them of a screw head popping off.

• Brand Name: 1.6MM X 8MM SCREW
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): OSTEOMED, LLC; 3885 arapaho rd; addison TX 75001
• Manufacturer (Section G): OSTEOMED, LLC; 3885 arapaho rd; addison TX 75001
• Manufacturer Contact: kimberly banning ; 3885 arapaho rd; addison, TX 75001
• MDR Report Key: 23525828
• Report Number: 2027754-2025-00052
• Device Sequence Number: 18692738
• Product Code: HWC
• UDI-Device Identifier: 00845694000987
• UDI-Public: 00845694000987
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K961418
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 11/11/2025

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: 208-1608
• Device Catalogue Number: 208-1608
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 11/11/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown