MAUDE Adverse Event Report: OSTEOMED, LLC 2.7 X 26MM FULLY THREADED ANGLED LOCKING; SCREW, FIXATION, BONE

Model Number	338-2726
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530)
Date of Event	08/28/2025
Type of Reportable Event	Serious Injury
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.Reports, including this one, for this complaint: (b)(4).
Event or Problem Description
It was reported that "eight years prior to his surgery, the patient reported a traumatic event due to a fall from a formwork roof, landing on the tip and in abduction of the midfoot, subsequently presenting over the following years with significant abduction deviation of the left foot at the expense of the talonavicular joint.Therefore, an arthrodesis of the medial column of the left foot was performed with a special titanium plate.The patient evolved poorly, with pain since the initiation of weight-bearing at 12 weeks.At 11 months, a revision surgery was performed, finding a talonavicular pseudarthrosis and severe metallosis.".
Additional Manufacturer Narrative
338-2726 - 2.7 x 26mm fully threaded angled locking screw, 4 each of them, were received.The screws do not show any signs of abuse or breakage, so no future action items are necessary.No definitive conclusion can be made.Related reports (including this one): 2027754-2025-00054, 2027754-2025-00055, 2027754-2026-00001, 2027754-2026-00002, 2027754-2026-00003, 2027754-2026-00004, 2027754-2026-00005, 2027754-2026-00006, 2027754-2026-00007.

• Brand Name: 2.7 X 26MM FULLY THREADED ANGLED LOCKING
• 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: 23406343
• Report Number: 2027754-2025-00056
• Device Sequence Number: 8791361
• Product Code: HWC
• UDI-Device Identifier: 00845694042635
• UDI-Public: 00845694042635
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K131445
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

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: 338-2726
• Device Catalogue Number: 338-2726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 30 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic
• Patient Race: White