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

Model Number	OSC-3545
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Date of Event	11/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Please note: the electronic submission of this report was delayed due to persistent problems in establishing the webtrader production account.Final release documentation related to osc-3545 lot 1709003 was reviewed.All test results were according to specification.Inspection of the records showed that inion has not received any other feedback related to this lot.Based on the information from customer, edema was noticed in the surgical site one month after the operation.Three months after operation the affected part was edematous and infected.Based on the degradation tests, release of the degradation by products from inion freedomscrew during the first 6 months is minimal.Polymer (screw shaft) in the picture of the removed screw shaft was still clear / transparent, which indicates also that degradation of the screw has not started yet.This is in line with the test reports.Thus it is highly unlikely that adverse event would have been caused by degradation of the screw / polymer.
Event or Problem Description
Female patient with syndesmosis injury was operated by an open reduction and internal fixation (orif) using inion freedomscrew¿ on (b)(6) 2018.Edema was noticed one month after the operation on (b)(6) 2018.Three months after the operation the affected part was edematous and infected.Implant was removed on (b)(6) 2019.

• Brand Name: INION FREEDOMSCREW
• Common Device Name: BONE SCREW
• Manufacturer (Section D): INION OY; lääkärinkatu 2; tampere, 33520 ; FI 33520
• MDR Report Key: 9841271
• Report Number: 3003407235-2019-00001
• Device Sequence Number: 765132
• Product Code: HWC
• UDI-Device Identifier: M224OSC35459
• UDI-Public: M224OSC35459
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K123672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/03/2019

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 Expiration Date: 09/01/2020
• Device Model Number: OSC-3545
• Device Catalogue Number: OSC-3545
• Device Lot Number: 1709006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 03/17/2020
• 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: Required Intervention
• Patient Age: 20 YR