MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-03-18 for FCD-2 9063-00 manufactured by Interventional Spine, Inc..
[19267738]
Follow-up x-ray revealed that the screw placed at l1-l-2 on left looked bent. Implant was placed on (b)(6) 2010. Implant was removed and found to be broken at screw. A new implant was placed next to piece that was broken.
Patient Sequence No: 1, Text Type: D, B5
[19445692]
Method of evaluation was interviewing the company staff present at the case: patient exhibited no pain or complaints. Removed stabilizer and 3 threads of the anchor. Doctor's comments: " probably placed too medial. " placing the implant too medial can result in undue stress on implant, causing it to break. Inspection of the implant observed a clean break at an angle; probably some sort of shear break. Trajectory of entry point and placement are critical and are explicitly defined in the surgical technique.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2032499-2011-00090 |
| MDR Report Key | 2062408 |
| Report Source | 05 |
| Date Received | 2011-03-18 |
| Date of Report | 2011-02-02 |
| Date of Event | 2011-02-02 |
| Date Mfgr Received | 2011-02-02 |
| Device Manufacturer Date | 2010-08-01 |
| Date Added to Maude | 2012-02-16 |
| 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 | 13700 ALTON PARKWAY SUITE 160 |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9494720006 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FCD-2 |
| Product Code | MRW |
| Date Received | 2011-03-18 |
| Model Number | 9063-00 |
| Catalog Number | 9063-00 |
| Lot Number | 062009-D |
| Device Expiration Date | 2011-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERVENTIONAL SPINE, INC. |
| Manufacturer Address | IRVINE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-03-18 |