MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2017-05-01 for PROSTHESIS XOM UNK PROSTHESIS manufactured by Medtronic Xomed Inc..
[74119255]
Product evaluation: analysis results not available; device not returned for evaluation. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[74119256]
An investigation of the results reported in? Transcanal endoscopic ear surgery for middle ear cholesteatoma? , glikson, et al; otology <(>&<)> neurotology, vol. 38, 2017. The objective of the study was to? Evaluate the clinical parameters, outcomes, and complications of transcanal endoscopic ear surgeries for middle ear cholesteatoma.? The population in the study consisted of? Adult patients (age>18) who underwent transcanal endoscopic ear surgeries for cholesteatoma, between march 2009 and march 2015.? Outcomes included postoperative complications for patients who underwent either total or partial ossicular replacement prosthesis placement. Of these,? One patient developed protrusion of the ossicular chain reconstruction prosthesis that necessitated surgical intervention.?
Patient Sequence No: 1, Text Type: D, B5
[101011423]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[101011424]
Additional information was received from the corresponding author confirming that the device reported in this article as having protruded was a non-medtronic prosthesis.
Patient Sequence No: 1, Text Type: D, B5
[101836312]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2017-00139 |
| MDR Report Key | 6535232 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2017-05-01 |
| Date of Report | 2017-04-06 |
| Date Mfgr Received | 2017-08-03 |
| Date Added to Maude | 2017-05-01 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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 DR 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 | PROSTHESIS |
| Generic Name | REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL |
| Product Code | ETA |
| Date Received | 2017-05-01 |
| Model Number | XOM UNK PROSTHESIS |
| Catalog Number | XOM UNK PROSTHESIS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2017-05-01 |