MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,08 report with the FDA on 2014-03-12 for MCP SZ. 30 PROXIMAL WW MCP-100-30P-WW manufactured by Ascension Orthopedics, Inc..
[4298090]
This is the second of two reports concerning the same patient. (see mfg report number 1651501-2014-00013). This report concerns the proximal mcp implant. It was reported the patient underwent surgery (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, patient 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
[11666460]
To date, the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651501-2014-00014 |
| MDR Report Key | 3687556 |
| Report Source | 04,08 |
| Date Received | 2014-03-12 |
| Date of Report | 2014-02-21 |
| Date Mfgr Received | 2014-02-21 |
| Date Added to Maude | 2014-03-20 |
| 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 | PLAINSBORO NJ 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 PROXIMAL WW |
| Generic Name | MCP |
| Product Code | NEG |
| Date Received | 2014-03-12 |
| Catalog Number | MCP-100-30P-WW |
| Lot Number | 12-2366 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCENSION ORTHOPEDICS, INC. |
| Manufacturer Address | AUSTIN TX 78754 US 78754 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-03-12 |