MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-08-07 for ASCENSION MCP MCP-100 MCP-100-30P manufactured by Ascension Orthopedics, Inc..
[894357]
Surgeon removed fractured implant due to pain.
Patient Sequence No: 1, Text Type: D, B5
[8113045]
Conclusions: fracture occurred in a rapid, brittle, bending mode. There were no indications of defects in the component. Stem fractures are known to occur surgically upon seating impact as a result of incomplete broaching of the medullary canal.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 1651501-2008-00013 |
MDR Report Key | 1106843 |
Report Source | 05 |
Date Received | 2008-08-07 |
Date of Report | 2008-08-06 |
Date of Event | 2008-04-18 |
Date Mfgr Received | 2008-07-01 |
Date Added to Maude | 2009-06-03 |
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 | 0 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 0 |
Event Location | 0 |
Manufacturer Contact | LYNN FERGUSON |
Manufacturer Street | 8700 CAMERON RD., STE. 100 |
Manufacturer City | AUSTIN TX 78754 |
Manufacturer Country | US |
Manufacturer Postal | 78754 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | ASCENSION MCP |
Generic Name | TOTAL FINGER JOINT IMPLANT |
Product Code | KWF |
Date Received | 2008-08-07 |
Returned To Mfg | 2008-07-07 |
Model Number | MCP-100 |
Catalog Number | MCP-100-30P |
Lot Number | UNK |
ID Number | NA |
Operator | LAY USER/PATIENT |
Device Availability | Y |
Device Age | DA |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | ASCENSION ORTHOPEDICS, INC. |
Manufacturer Address | 8700 CAMERON RD., STE. 100 AUSTIN TX 78754 US 78754 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2008-08-07 |