MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2010-01-11 for RADIAL IMPLANT, SMALL, LEFT 263200LF manufactured by Integra Lifesciences Corporation (integra Ohio).
[16370708]
The reported stated that during a total wrist implant procedure, the pt's radius was reamed ready to accept the radial implant. When the surgeon was seating prosthesis into the radius, the pt's radius fractured at the tip. The radial prosthesis was removed, and a burr was used to ream out the radial cortex to a larger size. The fracture around the stem of the prosthesis was stabilized with a 2. 7 dcp (dynamic compression plate); it is expected to heal well. The surgeon stated that the device's instruction for use ought to reflect that the actual implant is 2mm wider than the trial. The surgical procedure took about one hour longer than it would if the radius fracture had not occurred.
Patient Sequence No: 1, Text Type: D, B5
[16568532]
The device involved in the reported incident is not expected to be received for eval. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004608878-2010-00001 |
| MDR Report Key | 1576658 |
| Report Source | 05,07 |
| Date Received | 2010-01-11 |
| Date of Report | 2010-01-11 |
| Date of Event | 2009-12-29 |
| Date Mfgr Received | 2009-12-29 |
| Date Added to Maude | 2010-01-20 |
| 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 | SUSAN SCOTT |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099363604 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RADIAL IMPLANT, SMALL, LEFT |
| Generic Name | UNI2 TOTAL WRIST IMPLANT SYSTEM |
| Product Code | KWM |
| Date Received | 2010-01-11 |
| Catalog Number | 263200LF |
| Lot Number | 1004532L10570 |
| Device Expiration Date | 2011-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION (INTEGRA OHIO) |
| Manufacturer Address | CINCINNATI OH 45227 US 45227 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-01-11 |