MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-07-28 for SERENOCEM BC 010 manufactured by Corinthian Surgical Ltd..
[292229]
Serenocem otologic bone cement was used for extra fixation of vibrant sound bridge transducer to incus. During surgery a sudden rise in blood pressure resulted in the surg site being flushed with blood. During revision surgery to replace the non-functioning hearing device, it was discovered that the cement was no longer in place.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4003562 |
| MDR Report Key | 476882 |
| Date Received | 2003-07-28 |
| Date of Report | 2003-07-07 |
| Date Added to Maude | 2003-08-12 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SERENOCEM |
| Generic Name | OTOLOGIC BONE CEMENT |
| Product Code | NEA |
| Date Received | 2003-07-28 |
| Model Number | NA |
| Catalog Number | BC 010 |
| Lot Number | 0998176 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 465687 |
| Manufacturer | CORINTHIAN SURGICAL LTD. |
| Manufacturer Address | CROWN HOUSE HORNBEAM SQUARE NORTH HARROGATE, N. YORKSHIRE UK HG2 8PB |
| Baseline Brand Name | SERENOCEM |
| Baseline Generic Name | SERENOCEM |
| Baseline Model No | BC 010 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | SERENOCEM |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 36 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K003567 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-07-28 |