MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2011-09-15 for INION S-1 SPINAL GRAFT CONTAINMENT PLATE SPN-5011 manufactured by Inion Oy.
[17098333]
After a c5/6 acdf surgery, debridement and antibiotics 2 weeks post operative. Revision surgery of soft tissue abscess and implant removal 3 months post op. Observations: scar tissue in neck, no infection. Plate intact. Collapse of c5 onto cage seen in (b)(6) 2011 film (before the revision). Patient condition is reported good.
Patient Sequence No: 1, Text Type: D, B5
[17320055]
Local fluid accumulation: anticipated adverse event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9710629-2011-00010 |
| MDR Report Key | 2259108 |
| Report Source | 05,08 |
| Date Received | 2011-09-15 |
| Date of Report | 2011-09-13 |
| Date of Event | 2011-07-27 |
| Date Mfgr Received | 2011-08-15 |
| Device Manufacturer Date | 2008-11-01 |
| Date Added to Maude | 2011-09-23 |
| 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 SPINAL GRAFT CONTAINMENT PLATE |
| Generic Name | GRAFT CONTAINMENT PLATE |
| Product Code | OJB |
| Date Received | 2011-09-15 |
| Model Number | SPN-5011 |
| Catalog Number | SPN-5011 |
| Lot Number | 0811010 |
| Device Expiration Date | 2011-01-11 |
| 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 33530 FI 33530 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-09-15 |