MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2005-05-11 for INFIX 1804-514 manufactured by Abbott Spine.
[397697]
Doctor implanted an infix cage. The pt was turned over to implant posterior screws. A final film was taken for screw placement. At that time it was noticed that one of the struts in the infix cage was not properly aligned. Pt was then turned back over and reopened to remove any replace the device. This event caused a surgical delay of more than 30 minutes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649384-2005-00031 |
| MDR Report Key | 601897 |
| Report Source | 07 |
| Date Received | 2005-05-11 |
| Date of Report | 2005-05-09 |
| Date of Event | 2005-04-11 |
| Date Mfgr Received | 2005-04-14 |
| Date Added to Maude | 2005-05-16 |
| 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 | 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, LARGE, 14MM |
| Product Code | MOP |
| Date Received | 2005-05-11 |
| Returned To Mfg | 2005-04-20 |
| Model Number | NA |
| Catalog Number | 1804-514 |
| Lot Number | NI |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 591725 |
| Manufacturer | ABBOTT SPINE |
| Manufacturer Address | * AUSTIN TX * US |
| Baseline Brand Name | INFIX |
| Baseline Generic Name | STRUT, LARGE, 14MM |
| Baseline Model No | NA |
| Baseline Catalog No | 1804-514 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-05-11 |