MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-08-15 for RICHARDS * 70145892 manufactured by Gyrus Ent, Llc.
[414574]
When doctor picked it up to place it in the middle ear, the stem fell off, "no further description available. This is a product breakage associated with trimming. There is no adverse event, therefore according to the regulations this is not a reportable event. The device was not returned to the facility. The surgeon in the event never claims an adverse event. For all lots of this item number, this is the third such report in three years according to our database. Device: not returned, not available. No design changes related. Life expectancy and anticipated failure rate:na. This is a permanent implant for the middle ear. A more complete description of the investigation: made two attemps to obtain more information and a return from the user facility with no response. Reviewed sales and complaint database. Reviewed stock to see if the reported lot was available, and it is not.
Patient Sequence No: 1, Text Type: D, B5
[16266206]
Prosthesis was trimmed to size. When doctor picked it up to place it in the middle ear, the stem fell off.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 633305 |
| MDR Report Key | 633305 |
| Date Received | 2005-08-15 |
| Date of Report | 2005-08-15 |
| Date of Event | 2005-08-09 |
| Report Date | 2005-08-15 |
| Date Reported to FDA | 2005-08-15 |
| Date Added to Maude | 2005-09-07 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RICHARDS |
| Generic Name | EAR PROSTHESIS, OFF-CENTERED |
| Product Code | ETB |
| Date Received | 2005-08-15 |
| Model Number | * |
| Catalog Number | 70145892 |
| Lot Number | 0211119905 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 622869 |
| Manufacturer | GYRUS ENT, LLC |
| Manufacturer Address | 2925APPLING ROAD BARTLETT TN 38133 US |
| Baseline Brand Name | RICHARDS HAPEX OFFSET MALLEABLE PORP |
| Baseline Generic Name | PORP |
| Baseline Model No | NA |
| Baseline Catalog No | 70145892 |
| Baseline ID | NA |
| Baseline Device Family | PARTIAL OSSICULAR REPLACEMENT PROSTHESES |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K950886 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-08-15 |