MAUDE Adverse Event Report: INION OY INION BIORESTORE¿; BONE GRAFT

Model Number	1
Medical Device Problem Codes	Failure to Osseointegrate (1863); Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Impaired Healing (2378)
Date of Event	11/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Adult patient suffered from comminuted clavicle fracture which was accompanied by significant bone loss at fracture ends.Orif fracture fixation was conducted to the clavicle fracture with plate and screws and inion biorestore morsels were used to fill the noticed bone defect.A little over 5 months after original fracture fixation operation, follow-up ct showed fracture nonunion and absorption of the inion biorestore bioglass without bone formation.A revision surgery was conducted including removal of previous plate and screws, new autologous bone grafting was implanted and fracture was refixated with a distal clavicle locking plate (6-hole) and locking screws.As nonunion of clavicle fracture was identified and reoperation was required, this incident is reported as a serious injury.
Additional Manufacturer Narrative
No other complaints have been received related to this product batch, and the batch records show that the product batch is in specification.Even though the relation of the inion biorestore to the nonunion cannot be completely ruled out in this case, it is evaluated that nonunion could have happened in this case also with other bone grafts/bone graft substitutes as securing adequate immobilization/preventing constant micromovements and mechanical loading during the fracture healing period of comminuted clavicle fracture is challenging.The possible constant micromovements of the fracture site during post-operative follow-up time may be a contributing factor also in this case.Additionally, there was no information available if the patient had been following post-operative instructions.Also no information was available of the original bone defect shape and configuration after defect filling to evaluate the construct.Non-union is a known risk after comminuted clavicle fracture fixation surgeries.Non-union is also a recognized residual risk after bone grafting surgeries with bioglass bone graft substitutes like inion biorestore.Currently, based on the yearly inion biorestore post market surveillance data, the incidence of nonunion (complaints vs estimated number of operations) has consistently been less than 0.00%.Inion will continue to monitor these events as part of post-market activities.

• Brand Name: INION BIORESTORE¿
• Common Device Name: BONE GRAFT
• 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: 24159410
• Report Number: 3003407235-2026-00003
• Device Sequence Number: 9590070
• Product Code: MQV
• UDI-Device Identifier: 06438408003097
• UDI-Public: 06438408003097
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K070998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/31/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1
• Device Catalogue Number: BRS-5431
• Device Lot Number: 2501041
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2025
• Initial Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2025
• 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: METAL PLATE AND SCREWS (UNKNOWN MANUFACTURER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female