MAUDE Adverse Event Report: INION OY INION COMPRESSON¿ SCREW; BONE SCREW

Model Number	1
Medical Device Problem Codes	Failure to Osseointegrate (1863); Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Nonunion/Delayed-union Bone Fracture (2369); Impaired Healing (2378)
Date of Event	06/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Due to talonavicular, calcaneocuboidal and subtalar arthrosis (pes planovalgus), arthrodesis operations were conducted for the 59-year-old female patient with 5 inion compresson screws (listed below) approximately 2 years ago.Osh-4526, (lot 2109033), 1 screw.Osh-6070, (lot 2109046), 2 screws (reported separately).Osh-4545, (lot 2109040), 1 screw (reported separately).Osh-4550, (lot 2109041), 1 screw (reported separately).During operation 3 arthrodesis lines were fixated for fusion.No problems during operation.Cast was applied for 8 weeks postoperatively.No aes were detected at 6-week or 3-month postoperative follow-up.However, at 2 years post-op, patient reports of pain and swelling sensation in the operated foot.Pseudoarthrosis of 2/3 bone lines is identified based on x-ray.Based on the finding in x-ray and symptoms experienced by the patient, a re-operation was scheduled to be completed within 6 months with metal implants (the reoperation has not been conducted yet).
Additional Manufacturer Narrative
It was checked that inion has not received any other complaint, and there are no nonconformities related to the production batch.All dimensions and mechanical properties of the lot are within the specifications.Pseudoarthrosis is not an uncommon complication after triple arthrodesis operation of the foot.Usually the reasons behind nonunion/pseudoarthrosis are related to either patient-related factors such as certain comorbidies/smoking habits that affect bone quality or circulation, surgical technique related factors that relate to inadequate joint preparation or inadequate fixation or hardware failure or factors related to postoperative care such as poor compliance with immobilization protocols/early weight-bearing.In this case, the patient has multiple comorbidies that in combination might have a role in the development of pseudoarthrosis, however none are directly related to poor circulation or bone quality.No diabetes has been diagnosed and the patient is a non-smoker.In terms of fixation/surgical technique, the initial fixation achieved by the surgeon was evaluated good and no complications were detected within the 3 month initial post-operative follow-up.No information has been received whether the post-operative instructions have been applied by the patient.With the information received by inion, the role of inion compresson screws in the development of nonunion cannot be ruled out completely, however also patient-related factors and post-operative care related factors can have been involved.Even though there is no evidence of fixation failure within the first 3 months postoperatively, nonunion was detected at 2 years with pain and swelling symptoms.Thus, this incident should be reported to the fda as the involvement of the inion compresson screws cannot be undoubtedly ruled out and a reoperation with metal implants is planned to be conducted.It should however be noted that nonunion after triple arthrodesis is not uncommon even if metal implants are used.
Additional Manufacturer Narrative
Follow-up investigation determined that no non-union occurred.The initial report was submitted based on preliminary information.This event does not meet mdr reportability criteria and is considered invalid.Updated information: reoperation conducted (b)(6) 2025 (reoperation initially scheduled to (b)(6) 2025).Despite initial suspicion of symptomatic nonunion (pseudoarthrosis) in (b)(6) 2025, solid fusion was detected in reoperation (b)(6) 2025.The clinical symptoms prompting reoperation were ultimately attributed to arthrosis in another joint that was not included in the initial triple arthrodesis fusion, in which inion implants were used.Primary arthrodesis was conducted to that joint in the reoperation.The need for reoperation was due to pre-existing medical condition and thus this incident is not reportable.

• Brand Name: INION COMPRESSON¿ SCREW
• Common Device Name: BONE SCREW
• Manufacturer (Section D): INION OY; lääkärinkatu 2; tampere, 33520 ; FI 33520
• Manufacturer (Section G): INION OY; lääkärinkatu 2; tampere, 33520 ; FI 33520
• Manufacturer Contact: kati marttinen ; lääkärinkatu 2; tampere, 33520 ; FI 33520
• MDR Report Key: 22382032
• Report Number: 3003407235-2025-00010
• Device Sequence Number: 18245359
• Product Code: HWC
• UDI-Device Identifier: 06438408008610
• UDI-Public: 06438408008610
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K203105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2026

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 Expiration Date: 09/01/2024
• Device Model Number: 1
• Device Catalogue Number: OSH-4526
• Device Lot Number: 2109033
• 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: 06/26/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2021
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INION COMPRESSON¿ SCREW OSH-4545.; INION COMPRESSON¿ SCREW OSH-4550.; INION COMPRESSON¿ SCREW OSH-6070.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female