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

Model Number PLT-1008

Device Problem Device Appears to Trigger Rejection (1524)

Event Date 03/23/2023

Event Type  Injury  

Event Description

Inion plt-1008 was used in the lower eye orbital, and eyelid ectropion occured about two months later.Reoperation was needed.

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.

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
• Type of Device: 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
• MDR Text Key: 313710562
• Report Number: 3003407235-2023-00003
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 06438408000409
• UDI-Public: 06438408000409
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K010352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PLT-1083 LOT 2102038 RIGHT ORBITAL WO IMPL SCREWS; SCR-1222 LOT 2201003 (RIGHT LOWER ORBITAL)
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 55 KG