MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-12-01 for SMART STAPES PISTON * UNK manufactured by Gyrus Ent.
[17887628]
Reportedly a pt required a revision surgery 20 months post-op following a stapes replacement with a smart piston. During removal, the surgeon found that the prosthesis had extruded out of the footplate and off of the incus. According to the surgeon, based on the condition of the site. There appeared to be an allergic response. No device malfunction claim has been made. Two atempts at obtaining further info have been made with no success. No product has been returned to gyrus ent for evaluation. Nickel sensitivity is a known contraindication for the smart piston.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037007-2006-00005 |
| MDR Report Key | 798301 |
| Report Source | 05,06 |
| Date Received | 2006-12-01 |
| Date of Report | 2006-12-01 |
| Date Mfgr Received | 2006-11-01 |
| Date Added to Maude | 2006-12-28 |
| 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 | 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 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMART STAPES PISTON |
| Generic Name | PORP |
| Product Code | ETB |
| Date Received | 2006-12-01 |
| Model Number | * |
| Catalog Number | UNK |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 785833 |
| Manufacturer | GYRUS ENT |
| Manufacturer Address | * BARTLETT TN 38133 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-12-01 |