MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2005-05-31 for INFIX manufactured by Spinal Concepts.
[19952369]
It was reported: patient was revised in 2005 due to an infix strut backing out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649384-2005-00041 |
| MDR Report Key | 609843 |
| Report Source | 07 |
| Date Received | 2005-05-31 |
| Date of Report | 2005-05-31 |
| Date of Event | 2005-05-31 |
| Date Mfgr Received | 2005-05-31 |
| Date Added to Maude | 2005-06-06 |
| 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 Contact | SALINA MASON |
| Manufacturer Street | 5301 RAITA PARK COURT, BUILDING F. |
| Manufacturer City | AUSTIN TX 78727 |
| Manufacturer Country | US |
| Manufacturer Postal | 78727 |
| Manufacturer Phone | 5125331827 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INFIX |
| Generic Name | STRUT |
| Product Code | MOP |
| Date Received | 2005-05-31 |
| Model Number | NA |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 599651 |
| Manufacturer | SPINAL CONCEPTS |
| Manufacturer Address | * AUSTIN TX * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2005-05-31 |