MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-12-06 for PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT 70142004 manufactured by Gyrus Ent L.l.c..
[1652766]
Four months post-op the doctor discovered that the implant was broken. Removed the implant and replaced it.
Patient Sequence No: 1, Text Type: D, B5
[8906508]
The device has not been returned for eval. It is difficult to remove a porp without causing further damage. The likely condition of the implant will make it difficult to examine if returned. No other similar complaints on file for this item.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1037007-2010-00009 |
| MDR Report Key | 1917922 |
| Report Source | 06 |
| Date Received | 2010-12-06 |
| Date of Report | 2010-12-06 |
| Date of Event | 2010-11-24 |
| Date Mfgr Received | 2010-11-24 |
| Date Added to Maude | 2010-12-16 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. DOLAN MILLS |
| Manufacturer Street | 2925 APPLING RD. |
| Manufacturer City | BARTLETT TN 38133 |
| Manufacturer Country | US |
| Manufacturer Postal | 38133 |
| Manufacturer Phone | 9013730200 |
| Manufacturer G1 | GYRUS ENT L.L.C. |
| Manufacturer Street | 2925 APPLING RD. |
| 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, PARTIAL OSSICULAR REPLACEMENT |
| Product Code | ETB |
| Date Received | 2010-12-06 |
| Catalog Number | 70142004 |
| 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 ENT L.L.C. |
| Manufacturer Address | BARTLETT TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-12-06 |