MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07,company representati report with the FDA on 2014-11-24 for THE BIG EASY? PISTON 1156603 manufactured by Medtronic Xomed, Inc..
[5294424]
It was reported that a (b)(6) female patient suffered from? Loose wire? Syndrome after the implant of a 0. 5mm x 4. 5mm platinum/titanium prosthesis which became loose following the surgery. The doctor re-crimped the patient? S prosthesis during the first revision; however this did not correct the problem. So a second revision was performed, where the prosthesis was removed and replaced with a different brand of prosthesis. The doctor reports that this corrected the problem, as the? Distortion went away on the table and hearing result remained excellent.? There was no permanent patient impact or injury reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[12499882]
(b)(4). The device was returned, evaluation is anticipated but not yet begun. Method: no testing methods performed. Result: results pending completion of evaluation. This device is used for therapeutic purposes.
Patient Sequence No: 1, Text Type: N, H10
[26146590]
In response to medtronic? S request for device return, the device was returned to the manufacturer for evaluation purposes (detailed as follows): received 1 sample of part number 1156603 (big easy piston prosthesis), from an unknown lot number. There was evidence of biological contaminants [based off of the reactivity with hydrogen peroxide]. There were no non-conformities which would have resulted in the reported malfunction. Additionally, records indicate that every lot of platinum wire dating back to june 2012 have passed all inspections and there have been no recent changes to the manufacturing process. The complaint was not confirmed for the alleged malfunction [loose after procedure]. Based on the above observations; the underlying cause is not evident / unconfirmed failure.
Patient Sequence No: 1, Text Type: N, H10
[101038226]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2014-00303 |
| MDR Report Key | 4274421 |
| Report Source | 05,06,07,COMPANY REPRESENTATI |
| Date Received | 2014-11-24 |
| Date of Report | 2014-10-30 |
| Date of Event | 2014-10-30 |
| Date Mfgr Received | 2014-12-15 |
| Date Added to Maude | 2014-11-24 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | JACKLYN HAYMAN |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9042812769 |
| Manufacturer G1 | MEDTRONIC XOMED, INC. |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THE BIG EASY? PISTON |
| Generic Name | REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL |
| Product Code | ETA |
| Date Received | 2014-11-24 |
| Returned To Mfg | 2014-11-20 |
| Model Number | 1156603 |
| Catalog Number | 1156603 |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED, INC. |
| Manufacturer Address | 6743 SOUTHPOINT DRIVE NORTH JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-11-24 |