INION *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-02-19 for INION * manufactured by Inion Is A Finnish Company.

Event Text Entries

[1067840] We did a series of cervical surgery cases 2 years ago with a resonable plate and screws called "inion". We are now seeing a third case of what appears to be long term and unusual reactions to this resorbable product (3 pts so far). We did a small series of cases using resorbable plates and screws about 2 years ago. About 8 months after this, we saw a pt back who appeared to have some resorbtion of bone related to the plate and screws. We reported this to the mfr and kept a watchful eye on this. We tracked this online and with the mfr and found no similar cases. This pt did not require re-operation but is only now starting to fuse more solidly. A second case came through with a stable fusion but a cystic mass at the site of the plate that had to be removed due to swallowing difficulties. We are seeing a third case tomorrow with evidence on mri of both inadequate bone growth and cystic mass at the site of the plate. We do not see complications of this nature in any of the large volume of cases we do, using our standard titanium plates/screws. We believe that we are seeing a high rate of complications in this small sample of inion pts and we believe that it is related to the resorbable material. Note: all related scans, reports and md notes are in the respective pt charts. Dates of use: (2005 - 2006).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW4004371
MDR Report Key1328904
Date Received2009-02-19
Date of Report2009-01-21
Date Added to Maude2009-03-04
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameINION
Generic NameCERVICAL PLATE AND SCREWS
Product CodeOJB
Date Received2009-02-19
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age*
Device Sequence No1
Device Event Key0
ManufacturerINION IS A FINNISH COMPANY
Manufacturer Address* * *


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Other 2009-02-19

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