MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-11-08 for RE-MOTION * manufactured by Small Bone Innovations.
[1675462]
Procedure was going along fine until they tried to snap on the polyprolene to the metal implant. They took it apart and noted that it was not the right size. The manufacturer representative was in the or suite at the time and immediately notified his supervisor that the product was defective. ====================== health professional's impression======================the product was defective.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1909176 |
| MDR Report Key | 1909176 |
| Date Received | 2010-11-08 |
| Date of Report | 2010-11-08 |
| Date of Event | 2010-11-01 |
| Report Date | 2010-11-08 |
| Date Reported to FDA | 2010-11-08 |
| Date Added to Maude | 2010-11-29 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RE-MOTION |
| Generic Name | HAND IMPLANT |
| Product Code | KXE |
| Date Received | 2010-11-08 |
| Returned To Mfg | 2010-11-01 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMALL BONE INNOVATIONS |
| Manufacturer Address | 1380 SOUTH PENNSYLVANIA AVE MORRISVILLE PA 19067 US 19067 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-11-08 |