MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-08-12 for SPINE SYSTEM SW535T manufactured by Jbs, Sa.
[164350]
The surgical revision was completed on 08/15/96. The fractured screw on the left side of l4 and an unfractured screw on the right were explanted. Both screws were replaced with 7mm screws, along with additional rods and nuts. The linking plates were placed from side to side at l5 and l4 to add additional strength. The patient was in satisfactory condition post-op and at post-op office visit on 08/28/96, patient reported to be doing well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-1996-00003 |
| MDR Report Key | 38126 |
| Date Received | 1996-08-12 |
| Date of Report | 1996-08-12 |
| Date of Event | 1996-07-10 |
| Date Facility Aware | 1996-07-15 |
| Report Date | 1996-08-12 |
| Date Added to Maude | 1996-09-18 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| 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 | SPINE SYSTEM |
| Generic Name | BONE SCREW |
| Product Code | JBS |
| Date Received | 1996-08-12 |
| Model Number | NA |
| Catalog Number | SW535T |
| Lot Number | LT101 JG1 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 39396 |
| Manufacturer | JBS, SA |
| Manufacturer Address | PARC D'ACTIVITIES SAVIPOL SAINTE-SAVINE FR 10300 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 1996-08-12 |