MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-06-28 for TOTAL OSSICULAR REPLACEMENT PROSTHESIS 70145841 manufactured by Gyrus Ent Llc.
[20791110]
The customer reported that the head of the implant broke off in the pt's ear during implantation. Reporter believes that a piece remained in the pt, but is unsure if an add'l surgery was required.
Patient Sequence No: 1, Text Type: D, B5
[20971857]
The device has not been returned as of the date of this initial report. Add'l info has been requested, but so far it has not been provided. No other reports for this item in the last 5 yrs.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1037007-2011-00001 |
| MDR Report Key | 2170154 |
| Report Source | 06 |
| Date Received | 2011-06-28 |
| Date of Report | 2011-06-28 |
| Date of Event | 2011-05-25 |
| Date Mfgr Received | 2011-06-08 |
| Date Added to Maude | 2012-06-18 |
| 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 LLC |
| 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 | TOTAL OSSICULAR REPLACEMENT PROSTHESIS |
| Product Code | ETA |
| Date Received | 2011-06-28 |
| Catalog Number | 70145841 |
| 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 LLC |
| Manufacturer Address | BARTLETT TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-06-28 |