MAUDE Adverse Event Report: OSTEOMED, LLC 1.6MM X 5MM PROFILE ZERO AUTODRIVE SCREW; PLATE, CRANIOPLASTY, PREFORMED, ALTERABLE

Model Number	218-1605
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported in an email that, "the surgeon was using our cranial plating system to secure bone flap post craniotomy.When utilizing our 1.6mm auto-drive screws to secure our plates to bone flap the screws broke.The surgeon stated the "heads simply twisted off".".
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.

• Brand Name: 1.6MM X 5MM PROFILE ZERO AUTODRIVE SCREW
• Common Device Name: PLATE, CRANIOPLASTY, PREFORMED, ALTERABLE
• Manufacturer (Section D): OSTEOMED, LLC; 3885 arapaho rd; addison TX 75001
• Manufacturer (Section G): OSTEOMED, LLC; 3885 arapaho rd; addison TX 75001
• Manufacturer Contact: aram tran ; 3885 arapaho rd; addison, TX 75001
• MDR Report Key: 24540401
• Report Number: 2027754-2026-00012
• Device Sequence Number: 8971841
• Product Code: GWO
• UDI-Device Identifier: 00845694034265
• UDI-Public: 00845694034265
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111176
• 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): 03/06/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 218-1605
• Device Catalogue Number: 218-1605
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 03/07/2026
• 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