MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-06-01 for SIGMOID NOTCH 390-0315 manufactured by Small Bone Innovation.
[631040]
Osteoarthritis pt dislocated their ulna dorsally after implant surgery. Poly insert became dislodged from the sigmoid notch plate. Revision surgery was required to replace the poly insert.
Patient Sequence No: 1, Text Type: D, B5
[7962618]
Surgeon noted that the sigmoid notch component placement was not ideal due to somewhat abnormal anatomy of the ulna shaft. Dorsal dislocation of the ulna and dislodging of the poly insert from the sigmoid notch plate required revision surgery. A new poly piece was snapped onto the sigmoid notch plate. Care was taken to insure no soft tissue became lodged between the poly piece and the plated. Soft tissue was attached to the ulnar head implant's suture holes to further stabilize the joint.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003640913-2007-00004 |
| MDR Report Key | 859071 |
| Report Source | 07 |
| Date Received | 2007-06-01 |
| Date of Report | 2007-05-29 |
| Date of Event | 2007-04-11 |
| Date Mfgr Received | 2007-05-01 |
| Device Manufacturer Date | 2006-12-31 |
| Date Added to Maude | 2007-09-04 |
| 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 Country | US |
| Manufacturer Postal | 19067 |
| Manufacturer Phone | 2154281791 |
| Manufacturer G1 | SMALL BONE INNOVATIONS |
| Manufacturer Street | 1380 S. PENNSYLVANIA AVE. |
| Manufacturer City | MORRISVILLE PA 19067 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19067 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SIGMOID NOTCH |
| Generic Name | WRIST JOINT ULNAR (HEMI-WRIST) POLYMER |
| Product Code | KWN |
| Date Received | 2007-06-01 |
| Model Number | 390-0315 |
| Lot Number | 38209001 |
| Device Expiration Date | 2011-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 860003 |
| Manufacturer | SMALL BONE INNOVATION |
| Manufacturer Address | MORRISVILLE PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-06-01 |