MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03,literature report with the FDA on 2012-12-10 for PROSTHESIS 0529 CAUSSE FLEX H/A MICROLIT manufactured by Medtronic, Inc..
[2984193]
A literature review was performed on an article published in the journal "otology and neurotology" in 2011 entitled "ossiculoplasty in intact stapes and malleus patients: a comparison of porps versus torps with malleus relocation and silastic banding techniques," by robert vincent, maroeska rovers, nina mistry, john oates, neil sperling, and wilko grolman. The article discussed a study involving total ossicular replacement prosthesis (torp). Within the 318 ears operated on in the torp group, there were 43 failures; 28 of which underwent revision surgery during the follow-up period. Issues reported in the article: 1. ) short prosthesis (12 cases) 2. ) prosthesis extrusion (7 cases) 3. ) long prosthesis (3 cases) 4. ) prosthesis dislocation (1 case) 5. ) two patients were re-operated for a tm perforation, and the position of the previous torp was found to be correct in both cases. 6. ) in 2 cases, it was not possible to clearly identify the cause of failure at the time of revision, and the patients were therefore classified as having "negative findings" (malleus and stapes were normal, and the position of the previous prosthesis was correct with the presence of a clear round window reflex). Further ossicular chain erosion was identified at the time of the revision. 7. ) erosion of the stapes superstructure (7 cases) 8. ) malleus erosion (4 cases) 9. ) in 13 cases, the previous torp was removed and replaced with a new torp positioned from malleus to stapes footplate, and the silastic banding was used. Postoperative data were available for all cases (13 cases), with a mean follow-up of 11. 3 months. No postoperative snhl or prosthesis extrusion was observed in this group. Specific patient information was not provided.
Patient Sequence No: 1, Text Type: D, B5
[10335457]
This device is used for therapeutic purposes. (b)(4). This is being reported from a literature review. No devices will be returning. The device was not returned and therefore no evaluation could be performed. The following codes were not available in medtronic's gch system: method: actual device not evaluated; results: no results available since no evaluation performed; conclusion: device not returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2012-00701 |
| MDR Report Key | 2862725 |
| Report Source | 03,LITERATURE |
| Date Received | 2012-12-10 |
| Date of Report | 2012-11-06 |
| Date Mfgr Received | 2012-11-06 |
| Date Added to Maude | 2012-12-10 |
| 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 | JONATHAN SCHLECH |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328355 |
| 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 | PROSTHESIS 0529 CAUSSE FLEX H/A MICROLIT |
| Generic Name | REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL |
| Product Code | ETA |
| Date Received | 2012-12-10 |
| Model Number | 0529 |
| Catalog Number | 0529 |
| Lot Number | NOT PROVIDED |
| 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, INC. |
| Manufacturer Address | 6743 SOUTHPOINT DRIVE NORTH JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-12-10 |