MAUDE Adverse Event Report: INION OY INION FREEDOMPLATE; BONE FIXATION PLATE

Model Number FRF-1066

Device Problems Device Appears to Trigger Rejection (1524); Patient-Device Incompatibility (2682)

Patient Problem Foreign Body Reaction (1868)

Event Date 08/13/2020

Event Type  Injury  

Manufacturer Narrative

Two years after lateral malleolus fracture operation (b)(6) years old female patient had swelling in the operated area.The swelling increased significantly for a month.The patient had no pain and no fever.Purulent yellow liquid was seen after incision, and white endophyte debris was seen in the abscess cavity.The fracture has healed, the nail hole is enlarged, and there are absorbable nail fragments, which was considered a foreign body reaction.This type of tissue reactions are sterile (not caused by bacteria) and therefore the antibiotics are unlikely to help.Instead the patient should be given non-steroidal anti-inflammatory drugs (nsaids, e.G., ibuprofen).If the swelling does not go away, a puncture and needle aspiration (or small incision under local anesthesia) to remove the fluid accumulation (and any remaining material debris) is recommended.It is very unfortunate that this patient experienced this swelling.However, the number of patients experiencing this type of tissue reaction is very low ((b)(4)).Much lower than the frequency of metal plate removal due to e.G.Pain and discomfort caused by metal plates.Postoperative tissue reaction is a known risk which always exists when biodegradable implants are used.According to inion freedomplate ifu: "implantation of foreign materials can result in an inflammatory response or allergic reaction.Transient local fluid accumulation may occur in sterile circumstances." tissue reactions are possible when the device degrades.However, the occurrence rate has been reported to be very low with polylactic acid based implants.

Event Description

Two years after lateral malleolus fracture operation (b)(6) years old female patient had swelling in the operated area.The swelling increased significantly for a month.The patient had no pain and no fever.A second medical intervention was needed to reduce swelling.Purulent yellow liquid was seen after incision, and white endophyte debris was seen in the abscess cavity.The fracture has healed, the nail hole is enlarged, and there are absorbable nail fragments, which was considered a foreign body reaction.

• Brand Name: INION FREEDOMPLATE
• Type of Device: BONE FIXATION 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: 10487451
• MDR Text Key: 205479696
• Report Number: 3003407235-2020-00002
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K063410
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: FRF-1066
• Device Catalogue Number: FRF-1066
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2020
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 16 YR