MAUDE Adverse Event Report: INION OY INION CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM; PLATE, BONE

Model Number	PLT-1008
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Eye Irritation (4803)
Date of Event	03/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Inion plt-1008 was used in the lower eye orbital, and eyelid ectropion occured about two months later.Reoperation was needed.
Additional Manufacturer Narrative
Eyelid ectropion occurred about two months later after the plt-1008 was used in the orbital floor.It is unclear whether inion plate has contributed to the event, as eyelid ectropion is expected to be more dependent on the operation technique than the implants used.According to the information received, two surgeons provided their opinion stating that regardless whether an absorbable bone plate or the ao system is used at the orbital floor, there is a risk of eyelid ectropion, and this seems to be related to the method and technique of suturing, with no relation to the implants used.The ectropion is also not caused due to polymer degradation products, as the polymer degradation has hardly started at 2 months.Nevertheless, as a secondary surgery was conducted and the role of inion plates has not been explicitly closed out by the reporting surgeon, this event is reported.
Additional Manufacturer Narrative
The implant plt-1008 and screws were removed in the re-operation.At the time of receiving additional information, the ectropion had not yet resolved.On march 28, (b)(6) dr.Performed implant removal surgery.This operation took out plt-1008, but did not remove plt-1083, but there were still ectropion after the operation.In the case of eversion, the target did not do anything.(without implant anything just removed plt-1008 and screws).

• Brand Name: INION CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM
• Common Device Name: PLATE, BONE
• 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: 16783623
• Report Number: 3003407235-2023-00003
• Device Sequence Number: 14833434
• Product Code: JEY
• UDI-Device Identifier: 06438408000409
• UDI-Public: 06438408000409
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K010352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2023

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: PLT-1008
• Device Catalogue Number: PLT-1008
• Device Lot Number: 2103002
• 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: 03/27/2023
• Supplement Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 05/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2021
• 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: PLT-1083 LOT 2102038 RIGHT ORBITAL WO IMPL SCREWS; SCR-1222 LOT 2201003 (RIGHT LOWER ORBITAL)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 55 KG