MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-09-19 for SMART STAPES PISTON 70145928 manufactured by Gyrus Ent Llc.
[2199621]
The piston slipped off the incus soon after surgery and a revision surgery was required.
Patient Sequence No: 1, Text Type: D, B5
[9476932]
The surgeon initially phoned a company rep to discuss a concern about the smart pistons. He stated that over the course of the last 7 yrs using smart pistons multiple dislocations had occurred and that the frequency had increased in the last year. Later, when asked what he meant by dislocation, the surgeon replied that he meant that the smart prosthesis came off the incus after a certain period of time - not straight after the procedure. No further details were given. This implies poor hearing results and a revision surgery, however no medical professional has made that explicit claim. We have made multiple requests for the number of incidents the surgeon attributes to the device, the lot numbers, procedure dates, and current pt conditions, but so far we have not received any add'l details. No device has been returned. We are filing this report with the info available to us at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1037007-2011-00003 |
| MDR Report Key | 2259067 |
| Report Source | 01,05,06 |
| Date Received | 2011-09-19 |
| Date of Report | 2011-09-19 |
| Date Mfgr Received | 2011-09-02 |
| Date Added to Maude | 2012-07-06 |
| 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 |
| 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 STAPES PISTON |
| Product Code | ETB |
| Date Received | 2011-09-19 |
| Catalog Number | 70145928 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ENT LLC |
| Manufacturer Address | BARTLETT TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-09-19 |