MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1998-05-15 for FIXATION, COMPONENT manufactured by .
[16762395]
Cables were implanted on 4/1/98. The two most proximal cables loosened and were removed on 4/16/98.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825034-1998-00037 |
| MDR Report Key | 167660 |
| Report Source | 07 |
| Date Received | 1998-05-15 |
| Date of Event | 1998-04-16 |
| Date Mfgr Received | 1998-04-17 |
| Date Added to Maude | 1998-05-19 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | FIXATION, COMPONENT |
| Product Code | DZK |
| Date Received | 1998-05-15 |
| Returned To Mfg | 1998-04-17 |
| Model Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 163135 |
| Baseline Brand Name | STAINLESS STEEL CABLE |
| Baseline Generic Name | FIXATION, COMPONENT |
| Baseline Model No | NA |
| Baseline Catalog No | 350800 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-05-15 |