MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2014-08-01 for UNIVERSAL TITANIUM PROSTHESIS 1150000 manufactured by Medtronic Xomed Inc..
[4755882]
It was reported that? The prosthesis got broken and the shoe dropped into the patient? S inner ear. The doctor clamped the prosthesis very tightly, but the prosthesis got broken into two parts. The doctor spent about 20 minutes to pick up the fragments and cleaning the patient? S ear. Then, the doctor spent an extra 40 minutes to reinstall another new prosthesis. As a result, the operation was delayed for an hour.? There was no patient impact.
Patient Sequence No: 1, Text Type: D, B5
[12060070]
Blank fields on this report are the result of information not being provided by initial reporter. This device is used for therapeutic purposes. (b)(4). Product evaluation: when received for analysis there was evidence of biological contaminants [based off of the reactivity with hydrogen peroxide]. The flex h/a was separated from the titanium bell at the adhesive joint and still attached to the shaft. The flex h/a was removed from the shaft for further analysis. The head/shaft assembly measured less than 0. 11? [required is 0. 400 reference] and the shaft was consistent with being trimmed. When compared to the assembly drawing: when viewed under magnification, there was adhesive present at the break point between the flex h/a and bell which is consistent with proper manufacturing. Note: the instructions for use indicate that the shaft may be trimmed to length with scissors therefore it is not considered a malfunction. The information indicates the device was modified and mishandled which resulted in the malfunction. Results: fracture problem. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2014-00161 |
| MDR Report Key | 3973438 |
| Report Source | 01,05,07 |
| Date Received | 2014-08-01 |
| Date of Report | 2014-07-09 |
| Date of Event | 2014-07-07 |
| Date Mfgr Received | 2014-07-09 |
| Device Manufacturer Date | 2012-06-13 |
| Date Added to Maude | 2014-08-01 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHELLE ALFORD |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328197 |
| 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 | UNIVERSAL TITANIUM PROSTHESIS |
| Generic Name | REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL |
| Product Code | ETA |
| Date Received | 2014-08-01 |
| Returned To Mfg | 2014-07-09 |
| Model Number | 1150000 |
| Catalog Number | 1150000 |
| Lot Number | 0205967842 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR NORTH JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-08-01 |