MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2005-10-07 for KALIX FLAT FOOT IMPLANT EXTERNAL DIAM. 11MM * 140011 manufactured by Newdeal S.a..
[450981]
The implant when seated in the sinus and expanded would pop out when the foot was put through range of motion. 3 kilix implants were put in place for the same pt, but had the same problem. It was started that the surgeon operated with the proper technique. The pt received a debridment of the sinus tarsi. There was no pt injury reported. The surgery was lenthened about 30 minutes. The pt was not finally treated. No another kalix was put in place. The pt was deemed to be a poor candidate for another surgery and at this time, ano surgery occurred. The surgeon used trial implant to determine the size of the final endo prosthesis. This mdr is linked to 9615741-2005-00036 and 9615741-2005-00037.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615741-2005-00035 |
| MDR Report Key | 698315 |
| Report Source | 08 |
| Date Received | 2005-10-07 |
| Date of Report | 2005-10-07 |
| Date Mfgr Received | 2005-09-08 |
| Date Added to Maude | 2006-04-13 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | YANPING WANG |
| Manufacturer Street | 311C ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362322 |
| Manufacturer G1 | NEWDEAL S.A. |
| Manufacturer Street | 10 PLACE D'HELVETIE |
| Manufacturer City | LYON 69006 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 69006 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KALIX FLAT FOOT IMPLANT EXTERNAL DIAM. 11MM |
| Generic Name | KALIX SYSTEM |
| Product Code | HWL |
| Date Received | 2005-10-07 |
| Model Number | * |
| Catalog Number | 140011 |
| Lot Number | DOUC |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 687404 |
| Manufacturer | NEWDEAL S.A. |
| Manufacturer Address | * LYON FR |
| Baseline Brand Name | KALIX FLAT FOOT IMPLANT EXTERNAL DIAM. 11MM |
| Baseline Generic Name | KALIX SYSTEM |
| Baseline Model No | * |
| Baseline Catalog No | 140011 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-10-07 |