MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-05-06 for PROSTHESIS, PATIAL OSSICULAR REPLACEMENT 70145842 manufactured by Gyrus Ent, Llc.
[1498358]
The patient presented to the doctors office. The doctor discovered that the implant was broken. Removed the implant and replaced it with a new implant.
Patient Sequence No: 1, Text Type: D, B5
[8465383]
Device has not been received. It is difficult to remove a porp without causing further damage. The likely condition of the returned implant will make it difficult to examine.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1037007-2010-00007 |
| MDR Report Key | 1676969 |
| Report Source | 06 |
| Date Received | 2010-05-06 |
| Date of Report | 2010-05-06 |
| Date of Event | 2010-04-13 |
| Date Mfgr Received | 2010-04-13 |
| Device Manufacturer Date | 2008-10-01 |
| Date Added to Maude | 2010-05-12 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. DOLAN MILLS |
| Manufacturer Street | 2925 APPLING ROAD |
| Manufacturer City | BARTLETT TN 38133 |
| Manufacturer Country | US |
| Manufacturer Postal | 38133 |
| Manufacturer Phone | 9013730200 |
| Manufacturer G1 | GYRUS ENT LLC |
| Manufacturer Street | 2925 APPLING ROAD |
| Manufacturer City | BARTLETT TN 38133 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38133 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROSTHESIS, PATIAL OSSICULAR REPLACEMENT |
| Product Code | ETB |
| Date Received | 2010-05-06 |
| Catalog Number | 70145842 |
| Lot Number | 0837006439 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ENT, LLC |
| Manufacturer Address | BARTLETT TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-05-06 |