MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,08 report with the FDA on 2014-03-13 for MCP SZ. 30 DISTAL WW MCP-100-30D-WW manufactured by Ascension Orthopedics.
[4299268]
This is the first of two reports concerning the same pt. This report concerns the distal mcp implant. It was reported the pt underwent surgery on (b)(6) 2013 with the implantation of a mcp device in the middle finger of his right hand for an 'arthritis issue. ' early (b)(6) 2014 pt had an xray which showed mechanical loosening of implant; possible shearing. A revision surgery and explantation of the mcp device was performed on (b)(6) 2014. Add'l info was requested by integra.
Patient Sequence No: 1, Text Type: D, B5
[11620820]
To date, the device involved in the reported incident has not been rec'd for eval. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651501-2014-00013 |
| MDR Report Key | 3692559 |
| Report Source | 04,08 |
| Date Received | 2014-03-13 |
| Date of Report | 2014-02-21 |
| Date Mfgr Received | 2014-02-21 |
| Date Added to Maude | 2014-03-24 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CAREN FINKELSTEIN |
| Manufacturer Street | 315 ENTERPRISE DRIVE |
| Manufacturer City | AUSTIN TX 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MCP SZ. 30 DISTAL WW |
| Generic Name | MCP |
| Product Code | NEG |
| Date Received | 2014-03-13 |
| Catalog Number | MCP-100-30D-WW |
| Lot Number | 12-2236 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCENSION ORTHOPEDICS |
| Manufacturer Address | AUSTIN TX 78754 US 78754 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-03-13 |