MAUDE Adverse Event Report: INION OY INION FREEDOMSCREW; FIXATION SCREW

Model Number OSD-3540

Device Problems Biocompatibility (2886); Patient Device Interaction Problem (4001)

Patient Problem Foreign Body Reaction (1868)

Event Date 12/14/2017

Event Type  Injury  

Manufacturer Narrative

The pain and irritation were probably caused by implant degradation related tissue reaction.Also osteolysis was most likely caused by implant material degradation related tissue reaction.It is an anticipated but very rare adverse event.In case of biodegradable materials, possible material degradation related tissue reactions are caused by the acidic environment caused by the acidic degradation remnants of the material.If the local blood circulation and surrounding tissues are not able to clear the acidic remnants effectively enough, ph can decrease locally leading to osmotic accumulation of sterile fluid at the original implantation site.In rare cases the acidic effect can even lead to local osteolysis.The reaction is totally sterile and there is no bacteria involved.Usually the reaction resolves by itself latest when the implant material has fully degraded and been absorbed.

Event Description

Hallux ip arthrodesis was performed for a (b)(6) year old female patient with pes cavus.15 month post-op the patient reported pain in the great toe.Also possible osteolysis in the tip of the great toe was noticed from x-rays.The patient toe was re-operated 17 months postop.Debris was found in the distal tip of the hallux.The screw head was removed and the remaining screw shaft was left in place in the bone.No local fluid accumulation due to inflammation was seen in the operation.Four weeks after re-operation patient's toe was free from pain.

• Brand Name: INION FREEDOMSCREW
• Type of Device: FIXATION 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: 10579083
• MDR Text Key: 208303387
• Report Number: 3003407235-2020-00005
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K123672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: OSD-3540
• Device Catalogue Number: OSD-3540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR