MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-09-07 for RE-MOTION TOTAL WRIST SYSTEM IMPLANTS WA/C-S manufactured by Small Bone Innovations, Inc..
[16398666]
Total wrist implant was removed due to pain and the wrist was fused.
Patient Sequence No: 1, Text Type: D, B5
[16520624]
Medical review of clinical notes show the patient's previous surgical procedures (capsulodesis and proximal row carpectomy) prior to the total wrist implant, and the total wrist implant could not eliminate pain due to wrist motion. The final option was to fuse the wrist. Review of x-ray post-op reveals broken carpal screw likely the result of placement in anatomy complicated by previous surgeries. Model# wa/r-rs, lot# 35899005.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003640913-2007-00005 |
| MDR Report Key | 909912 |
| Report Source | 07 |
| Date Received | 2007-09-07 |
| Date of Report | 2007-09-05 |
| Date of Event | 2007-07-16 |
| Date Mfgr Received | 2001-08-01 |
| Date Added to Maude | 2007-10-17 |
| 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 | JAMES O'CONNOR, VP |
| Manufacturer Street | 1380 S. PENNSYLVANIA AVE. |
| Manufacturer City | MORRISVILLE PA 19067 |
| Manufacturer Postal | 19067 |
| Manufacturer Phone | 2154281791 |
| Manufacturer G1 | SMALL BONE INNOVATIONS |
| Manufacturer Street | 1380 S. PENNSYLVANIA AVE. |
| Manufacturer City | MORRISVILLE PA 19067 |
| Manufacturer Postal Code | 19067 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RE-MOTION TOTAL WRIST SYSTEM IMPLANTS |
| Generic Name | WRIST PROSTHESIS |
| Product Code | KWN |
| Date Received | 2007-09-07 |
| Model Number | WA/C-S |
| Lot Number | 35899007 |
| Device Expiration Date | 2011-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 890371 |
| Manufacturer | SMALL BONE INNOVATIONS, INC. |
| Manufacturer Address | MORRISVILLE PA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-09-07 |