MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-06-28 for SMART 360 PISTON, .6MM X 4.25MM 70143662 manufactured by Gyrus Acmi, Inc..
[2828875]
Surgeon performed a stapedectomy on patient on (b)(6) 2010, during which the surgeon implanted a smart 360 stapes piston prosthetic. Pt's hearing was initially improved post-surgery, but within a short period of time thereafter his hearing declined to the extent that it was worse than it had been pre-surgery. On (b)(6) 2011, surgeon performed another surgery and replaced the smart 360 stapes piston with a richards stapes piston. Surgeon claims the original device was found detached and was defective.
Patient Sequence No: 1, Text Type: D, B5
[9975490]
Device is not available for return. Lot consisted of 40 pieces. No other adverse events on file for this item or lot.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1037007-2012-00004 |
| MDR Report Key | 2640438 |
| Report Source | 05,06 |
| Date Received | 2012-06-28 |
| Date of Report | 2012-06-28 |
| Date of Event | 2011-12-20 |
| Date Mfgr Received | 2012-06-05 |
| Device Manufacturer Date | 2008-10-18 |
| Date Added to Maude | 2012-08-07 |
| 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 | DOLAN MILLS |
| Manufacturer Street | 2925 APPLING RD. |
| Manufacturer City | BARTLETT TN 38133 |
| Manufacturer Country | US |
| Manufacturer Postal | 38133 |
| 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 | SMART 360 PISTON, .6MM X 4.25MM |
| Product Code | ETB |
| Date Received | 2012-06-28 |
| Catalog Number | 70143662 |
| Lot Number | 0841394698 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC. |
| Manufacturer Address | BARTLETT TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-06-28 |