MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2013-09-04 for TRAPEZX manufactured by Extremity Medical Llc.
[19731304]
Trapezium implanted removed due to mild soreness (pt pain) based on retrospective data collection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007289093-2013-00022 |
| MDR Report Key | 3337977 |
| Report Source | 08 |
| Date Received | 2013-09-04 |
| Date of Report | 2013-07-29 |
| Date of Event | 2012-01-01 |
| Date Mfgr Received | 2013-07-29 |
| Date Added to Maude | 2013-09-11 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | BRIAN SMEKAL |
| Manufacturer Street | 300 INTERPACE PKWY STE 410 |
| Manufacturer City | PARSIPPANY NJ 07054 |
| Manufacturer Country | US |
| Manufacturer Postal | 07054 |
| Manufacturer Phone | 9735888988 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRAPEZX |
| Generic Name | NONE |
| Product Code | KYI |
| Date Received | 2013-09-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EXTREMITY MEDICAL LLC |
| Manufacturer Address | PARSIPPANY NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-04 |