MAUDE Adverse Event Report: OSTEOMED, LLC 1.6MM X 4MM PROFILE ZERO AUTODRIVE SCREW; SCREW, FIXATION, BONE

Model Number	218-1604
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Acumed communicated with the patient, who supplied the date of surgery, the surgeon and location of the surgery.The scope of the recall that was in question by the patient for their reported pain, migraines and seizures, did not include any parts utilized during the patient's surgery.The scope was for manufactured dates years after the surgery took place.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 in an email from the patient, "i had surgery using your parts, recall z-2107-2023.My skull platelets have been moving around in pieces for years and if i had known to let my doctor know i could have gotten them replaced.I thought that it was normal for them to not stick together.I've made an appointment with the surgeon to get them replaced and i'm looking into what i can do to get compensated for the pain, migraines and seizures that i've been having due to this.".

• Brand Name: 1.6MM X 4MM PROFILE ZERO AUTODRIVE 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: aram tran ; 3885 arapaho rd; addison, TX 75001
• MDR Report Key: 24328863
• Report Number: 2027754-2026-00008
• Device Sequence Number: 13180361
• Product Code: HWC
• UDI-Device Identifier: 00845694034258
• UDI-Public: 00845694034258
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K111176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/12/2026

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: 218-1604
• Device Catalogue Number: 218-1604
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 02/12/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female