MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-11-05 for EBI XFIX DYNAFIX 04003 manufactured by Ebi Medical Systems, Inc..
[135988]
During a follow-up visit the md wanted to take the patient out of dorsey flexion. When he loosened the ball joint it would not retighten. Another fixator was placed on the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2242816-1999-00061 |
| MDR Report Key | 249427 |
| Report Source | 05 |
| Date Received | 1999-11-05 |
| Date of Report | 1999-11-04 |
| Date Mfgr Received | 1999-11-04 |
| Date Added to Maude | 1999-11-15 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL TAGGART, SR. DIRECTOR |
| Manufacturer Street | 100 INTERPACE PARKWAY |
| Manufacturer City | PARSIPPANY NJ 07054 |
| Manufacturer Country | US |
| Manufacturer Postal | 07054 |
| Manufacturer Phone | 9732999022 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EBI XFIX DYNAFIX |
| Generic Name | EXTERNAL FIXATION |
| Product Code | HJI |
| Date Received | 1999-11-05 |
| Model Number | 04003 |
| Catalog Number | 04003 |
| Lot Number | 133110 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 241651 |
| Manufacturer | EBI MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 3 ENTIN ROAD PARSIPPANY NJ 07054 US |
| Baseline Brand Name | EBI XFIX DYNAFIX |
| Baseline Generic Name | EXTERNAL FIXATION |
| Baseline Model No | 04003 |
| Baseline Catalog No | 04003 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-11-05 |