MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2008-01-28 for SMART STAPES PISTON 70145926 manufactured by Gyrus Ent.
[15697956]
Reportedly, a pt required a revision surgery several months post-op following a stapes replacement with a smart piston. According to the surgeon the memory wire crook would not crimp when heated with a laser, and therefore the wire was manually crimped. According to the surgeon the pt did not have good hearing results following the surgery so the revision surgery was scheduled. The pt was revised in 2008 with a new smart piston with no problems noted and good post-op results.
Patient Sequence No: 1, Text Type: D, B5
[15926989]
The returned implant meets print specs. The memory wire crimps when heat is applied using the gyrus ent portable heating device. Tried three times and each time the wire closed when the proper amount of heat was applied.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1037007-2008-00001 |
| MDR Report Key | 985886 |
| Report Source | 05,06,07 |
| Date Received | 2008-01-28 |
| Date of Report | 2008-01-28 |
| Date Mfgr Received | 2008-01-11 |
| Device Manufacturer Date | 2004-10-01 |
| Date Added to Maude | 2008-04-24 |
| 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 | 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 |
| 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 | 2008-01-28 |
| Returned To Mfg | 2008-01-24 |
| Catalog Number | 70145926 |
| Lot Number | 0447047318 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 991786 |
| Manufacturer | GYRUS ENT |
| Manufacturer Address | BARTLETT TN 38133 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-01-28 |