MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-02-19 for INION S-1 GRAFT CONTAINMENT SYSTEM PLATE * manufactured by Inion Oy.
[1032512]
Acdf, c5-6. Solid fusion, but swallowing difficulties, abnormal cystic mass (same shape and size as the plate) and liquid formation 1. 5 years post-operatively. Re-operation performed for cyst removal (inflammatory tissue). Pt is doing fine.
Patient Sequence No: 1, Text Type: D, B5
[8218877]
The primary aim of the procedure i. E. , solid fusion was successfully achieved, but re-operation was needed 1. 5 years post-operatively to solve the swallowing problems caused by material degradation related local soft tissue reaction / fluid accumulation (adverse event / anticipated risk). It should be noted that several foreign materials were used together in these procedures (biodegradable polymer, peek, and beta-tricalcium phosphate). The degradation related tissue reactions typically occur earliest approx 1. 5 - 2 yrs postoperatively, i. E. , when the implant degrades, which is most likely the cause of the masses seen. Please note the following statements in the instruction for use in the inion s-1 system: implantation of foreign materials can result in an inflammatory response or allergic reaction. Transient local fluid accumulation may occur in sterile circumstances. More than 2000 inion s-1 plates have been sold since the product was launched 2005/2006. Identical cases not previously reported to inion.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9710629-2009-00001 |
| MDR Report Key | 1328973 |
| Report Source | 05,06 |
| Date Received | 2009-02-19 |
| Date of Report | 2009-01-27 |
| Date of Event | 2008-11-11 |
| Date Mfgr Received | 2009-01-27 |
| Date Added to Maude | 2009-03-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | LAAKARINKATU 2 |
| Manufacturer City | TAMPERE 33520 |
| Manufacturer Country | FI |
| Manufacturer Postal | 33520 |
| Manufacturer Phone | 08306600 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INION S-1 GRAFT CONTAINMENT SYSTEM PLATE |
| Generic Name | OJB: SPINAL INTERVERT. BODY FIXATION ORTH |
| Product Code | OJB |
| Date Received | 2009-02-19 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INION OY |
| Manufacturer Address | LAAKARINKATU 2 TAMPERE 33520 FI 33520 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2009-02-19 |