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..
[325937]
Due to unexplained trauma pt had suffered fracture of ossicular chain (long process of incuc and stapes) following middle ear transducer implant. Serenocem otologic bone cement was used to restore ossicular chain to natural physical state prior to re-implanting transducer. After initial good audiometric results deteriorated, revision surgery showed serenocem to have dislocated and partially disintegrated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4003561 |
| MDR Report Key | 476875 |
| 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 | NI |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 465681 |
| 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 |