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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INION OY INION CPS BIOABSORBABLE MESH PLATES; BONA PLATE
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INION OY INION CPS BIOABSORBABLE MESH PLATES; BONA PLATE Back to Search Results
Device Problems Biocompatibility (2886); Patient Device Interaction Problem (4001)
Patient Problems Foreign Body Reaction (1868); Fluid Discharge (2686)
Event Date 10/02/2017
Event Type  Injury  
Manufacturer Narrative
Inion cps® mesh plate was used in orbital floor repair for a (b)(6) year old man.Fluid accumulation was noticed 2.5 months post operatively, and 3.5cc of fluid was drained out by percutaneous needle aspiration.The needle aspiration was repeated 3 times during 8 - 10 months post operatively.No growth of bacteria has been found in fluid collection.The number of patients experiencing this type of tissue reaction is very low.Occurrence rate of degradation related tissue reactions (inion cps®) is 0,15 % as reported to inion.Fluid accumulation is a known adverse event with the bioabsorbable implants, especially if metabolism/vascularity is locally reduced or poor.Tissue reactions such as this are rare, but may occur 1-2 years postoperatively when the device starts to degrade, especially when a plate is implanted under a thin soft tissue layer.Such reaction does not affect bone healing negatively, or cause permanent damage or impairment.The occurrence rate of degradation related tissue reactions has been reported to be very low with polylactic acid based implants, which is in line with inion's post market data.
 
Event Description
Inion cps® mesh plate was used in orbital floor repair for a (b)(6) year old man.Fluid accumulation was noticed 2.5 months post operatively, and 3.5cc of fluid was drained out by percutaneous needle aspiration.The needle aspiration was repeated 3 times during 8 to 10 months post operatively.No growth of bacteria has been found in fluid collection.
 
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Brand Name
INION CPS BIOABSORBABLE MESH PLATES
Type of Device
BONA 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 Key10579082
MDR Text Key208303575
Report Number3003407235-2020-00004
Device Sequence Number1
Product Code JEY
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K010352
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 09/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/09/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age51 YR
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