MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-04-25 for S-1 * manufactured by Inion, Inc.
[4440077]
Patient in surgery for anterior cervical discectomy with fusion. During surgery, 3 inion cervical plates cracked while surgeon was posting them to the patient's cervical vertebrae. It appears the correct temperature of the water may not have been met.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3783387 |
| MDR Report Key | 3783387 |
| Date Received | 2014-04-25 |
| Date of Report | 2014-03-13 |
| Date of Event | 2014-03-12 |
| Report Date | 2014-03-13 |
| Date Reported to FDA | 2014-04-25 |
| Date Reported to Mfgr | 2014-05-01 |
| Date Added to Maude | 2014-05-01 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | S-1 |
| Generic Name | RESORBABLE SPINAL INTERVERTEBRAL |
| Product Code | OJB |
| Date Received | 2014-04-25 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 1301002 1303026X2 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INION, INC |
| Manufacturer Address | 2800 GLADES CIRCLE SUITE 138 WESTON FL 33327 US 33327 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-25 |