MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2011-08-31 for INION S-1 BIODEGR. GRAFT CONTAINMENT PLATE SPN-5017 manufactured by Inion Oy.
[16123146]
Pt had a c5-c7 inion plate for an acdf in (b)(6) 2011. The pt developed loss of her lordotic curvature after the surgery on f/u films: reversal of lordosis at c5-7. Partial collapse of c4/5 also. In the revision surgery the inion plate and screws were removed. The screw heads were found loose which according to surgeon may or may not have occurred during dissecting fibrous tissue off the plate. The plate cracked into two during removal. The pt then was reconstructed with a new c4/5 acdf and revision of the c5/6 fusion and placement of a new cage in the c5/6 space in addition to the cage that was already there. Then a metal plate was used from c4-7 to complete the procedure. Surgeon conclusion is loss of bone structure. The pt had been in motor vehicle accident prior to the operation.
Patient Sequence No: 1, Text Type: D, B5
[16244387]
Part 6: eval and conclusion will be provided in a f/u report after completion.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9710629-2011-00009 |
| MDR Report Key | 2236980 |
| Report Source | 05,08 |
| Date Received | 2011-08-31 |
| Date of Report | 2011-08-31 |
| Date of Event | 2011-06-22 |
| Date Mfgr Received | 2011-06-30 |
| Device Manufacturer Date | 2008-04-01 |
| Date Added to Maude | 2011-09-08 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | LAAKARINKATU 2 |
| Manufacturer City | TAMPERE 33520 |
| Manufacturer Country | FI |
| Manufacturer Postal | 33520 |
| Manufacturer Phone | 108306600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INION S-1 BIODEGR. GRAFT CONTAINMENT PLATE |
| Generic Name | GRAFT CONTAINMENT PLATE |
| Product Code | OJB |
| Date Received | 2011-08-31 |
| Model Number | SPN-5017 |
| Catalog Number | SPN-5017 |
| Lot Number | 0804052 |
| Device Expiration Date | 2011-04-01 |
| Operator | HEALTH PROFESSIONAL |
| 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. Required No Informationntervention | 2011-08-31 |