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

Model Number PLT-1008

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fistula (1862); Foreign Body Reaction (1868)

Event Date 03/03/2022

Event Type  Injury  

Manufacturer Narrative

Inion cps 1.5 system 7-hole c-plate combined with inion cps 1.5 x 6mm screws was used in orbital reconstruction after orbital tumor resection.The bone flap healed well but second surgery was needed approximately 1 year after postoperatively for removal of eyelid fistula and remaining implant remnants.The primary aim of the first surgery, i.E., acceptable orbital reconstruction, was successfully achieved.However, eyelid fistula developed and a second surgery was needed to get rid of it.The patient had exudate in the outer corner of the eye for approximately 1 year (from 2 weeks postoperatively until the second surgery was finally performed).The development of the observed eyelid fistula may have been related to the used implants (i.E., foreign objects in the body) and/or to the surgery in general.Tissue reactions related to the biodegradable inion implants are rare, but possible.Fluid accumulation is a known adverse event with the bioabsorbable implants, especially if metabolism/vascularity is locally reduced or poor.The degradation related tissue reactions are usually temporary and resolve over time, but may sometimes require second procedure for removal of fluid accumulation, possible granulation / scar tissue, and remaining implant remnants.

Event Description

One year after left orbital incision and orbital tumor resection a re-operation was conducted due to left eyelid fistula, when conservative approach had not worked such as cleaning and disinfecting the area.Implant remnants were removed.No obvious abscess cavity was found around the bone plate and orbital cavity.The patient's condition is reported good.

• Brand Name: INION CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM
• Type of Device: BONE PLATE
• 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: 13963211
• MDR Text Key: 288274228
• Report Number: 3003407235-2022-00001
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 06438408000409
• UDI-Public: 06438408000409
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K010352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• 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: 2004019
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2020
• 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: INION CPS SCREW, SCR-1223, UDI: (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian