MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-08 for MICRON II 2.5MM OCTR ALL TITANIUM PORP 70142030 manufactured by Gyrus Acmi, Inc.
[132622807]
The device is not expected to be returned as it is reportedly not available. In addition, insufficient information regarding the details of the reported event were provided. Multiple follow-ups were made to obtain additional information, but with no results. No dhr records could be reviewed as there was no lot number reported. In addition, there was no purchase record available. The cause of the reported event cannot be confirmed. However, if additional information becomes available this report will be supplemented accordingly.
Patient Sequence No: 1, Text Type: N, H10
[132622808]
Olympus was informed that the partial ossicular replacement prosthesis device was installed in the patient's ear in 2014 and broke inside the patient two years later. In (b)(6)2016, the patient had consulted a specialist who informed the patient the device had reportedly broken in two pieces and an intervention procedure at another hospital was performed to remove and replace the broken device with a non-olympus device. It was also reported the patient was kept for an extended period. A follow-up was conducted on the patient in (b)(6) 2016, and the patient is reportedly doing fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00341 |
| MDR Report Key | 8229995 |
| Date Received | 2019-01-08 |
| Date of Report | 2019-04-17 |
| Date of Event | 2018-09-11 |
| Date Mfgr Received | 2019-03-27 |
| Date Added to Maude | 2019-01-08 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355124 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MICRON II 2.5MM OCTR ALL TITANIUM PORP |
| Generic Name | MICRON II ALL TITANIUM OFFCENTERED PORP |
| Product Code | ETA |
| Date Received | 2019-01-08 |
| Model Number | 70142030 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-01-08 |