MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2004-08-02 for SMART 70145924 manufactured by Gyrus Ent.
[18147018]
It was reported that approx 5 months post-op stapedotomy the pt experienced a loss of hearing and exploratory surgery revealed that the loop of the prosthesis had lateralized on the incus. The prosthesis was replaced without incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037007-2004-00008 |
| MDR Report Key | 537384 |
| Report Source | 07 |
| Date Received | 2004-08-02 |
| Date of Report | 2004-07-06 |
| Date of Event | 2004-06-24 |
| Report Date | 2004-07-06 |
| Date Mfgr Received | 2004-07-06 |
| Device Manufacturer Date | 2003-07-01 |
| Date Added to Maude | 2004-08-04 |
| 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 | 3 |
| Manufacturer Contact | MR. GREG SREDIN |
| Manufacturer Street | 2925 APPLING RD |
| Manufacturer City | BARTLETT TN 38133 |
| Manufacturer Country | US |
| Manufacturer Postal | 38133 |
| Manufacturer Phone | 9013730200 |
| Manufacturer G1 | GYRUS ENT |
| Manufacturer Street | 2925 APPLING ROAD |
| Manufacturer City | BARLETT 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 |
| Generic Name | PARTIAL OSSICULAR REPLACEMENT PROSTHESIS |
| Product Code | ETB |
| Date Received | 2004-08-02 |
| Returned To Mfg | 2004-07-06 |
| Model Number | NA |
| Catalog Number | 70145924 |
| Lot Number | 0336842768 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 5 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 526632 |
| Manufacturer | GYRUS ENT |
| Manufacturer Address | 2925 APPLING RD. BARTLETT TN 38133 US |
| Baseline Brand Name | SMART |
| Baseline Generic Name | PISTON |
| Baseline Model No | NA |
| Baseline Catalog No | 70145924 |
| Baseline ID | NA |
| Baseline Device Family | SMART STAPES PISTON PROSTHESES |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K003214 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2004-08-02 |