MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-05-23 for PROSTHESIS - CAPCEL 1112197 manufactured by Medtronic Xomed Inc..
[45715327]
Product evaluation: analysis results not available; evaluation expected but not yet begun. 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
[45715328]
It was reported that during implantation,? The polycel shaft broke off from the titanium shaft connection to the head. All portions of the broken implants were removed from the patient.? This occurred with 2 prosthesis during this event. There was no patient impact; a different product was used in their place.
Patient Sequence No: 1, Text Type: D, B5
[46414210]
Date of this report: 4/28/2016. Date manufacturer received: 5/24/2016. Product evaluation: the product is shipped in a ridged capsule which likely indicates the devices were not damaged in shipping. When compared to the assembly drawing: visually, the polycel had separated from the stainless steel cores which would have resulted in the reported event. The core is imbedded into the polycel by approximately 0. 012" deep according to the drawing and polycel is porous structural foam which makes it susceptible to any sort of mishandling. It was reported that the devices broke during implantation and there was no allegation that they were broke prior to handling. The complaint was confirmed for the alleged malfunction [detached]. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[102521073]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2016-00163 |
| MDR Report Key | 5673639 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-05-23 |
| Date of Report | 2016-04-28 |
| Date of Event | 2016-04-28 |
| Date Mfgr Received | 2016-05-24 |
| Device Manufacturer Date | 2015-08-31 |
| Date Added to Maude | 2016-05-23 |
| 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 - CAPCEL |
| Generic Name | REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL |
| Product Code | ETA |
| Date Received | 2016-05-23 |
| Returned To Mfg | 2016-05-18 |
| Model Number | 1112197 |
| Catalog Number | 1112197 |
| Lot Number | 0210073879 |
| 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 DR NORTH JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-23 |