MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,litera report with the FDA on 2017-08-04 for PROSTHESIS XOM UNK PROSTHESIS manufactured by Medtronic Xomed Inc..
[81847938]
Product evaluation: analysis results are not available; devices not returned for evaluation. *note: this article reports product extrusion and too short of an implant as reasons for revisions. Both of these reported reasons are being filed as separate mdr's, both with the same reference number, (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[81847939]
Results reported in the literature article? Transcanal endoscopic ear surgery for middle ear cholesteatoma? , glikson, e. , et al, otology <(>&<)> neurotology, vol. 38, no. Xx, 2017, indicate that out of 123 total ossicular chain reconstruction procedures, 29 patients required revisions due to displaced or extruded prosthesis. The objective of the research:? Ossicular chain disruption in children leads to conductive hearing loss. Few studies have focused on factors influencing successful results in pediatric ossicular chain reconstruction (ocr). We aim to determine whether demographic or surgical factors affect hearing outcomes in pediatric ocr.? The authors confirm that? All revision cases were completed to improve hearing outcomes. "
Patient Sequence No: 1, Text Type: D, B5
[101833393]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[101833394]
Correct title of journal article:? Factors influencing hearing outcomes in pediatric patients undergoing ossicular chain reconstruction? , n. Govil, et al. ; international journal of pediatric otorhinolaryngology 99 (2017) 60-65. Http://dx. Doi. Org/10. 1016/j. Ijporl. 2017. 05. 022
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-2017-00268 |
| MDR Report Key | 6768067 |
| Report Source | COMPANY REPRESENTATIVE,LITERA |
| Date Received | 2017-08-04 |
| Date of Report | 2017-07-07 |
| Date Mfgr Received | 2017-09-17 |
| Date Added to Maude | 2017-08-04 |
| 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 | 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 | 2017-08-04 |
| 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 | 2017-08-04 |