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 |