MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2006-02-10 for KALIX FLAT FOOT IMPLANT EXTERNAL DIAM. 13MM * 140013 manufactured by Newdeal S.a..
[451972]
User facility reported that the plastic coating was pushing over metal several times during a surgery in 2005. There was another device available to complete the surgery. No patient injury or surgery delay was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615741-2006-00003 |
| MDR Report Key | 676012 |
| Report Source | 08 |
| Date Received | 2006-02-10 |
| Date of Report | 2006-02-09 |
| Date Mfgr Received | 2006-01-11 |
| Date Added to Maude | 2006-02-16 |
| 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. 13MM |
| Generic Name | KALIX SYSTEM |
| Product Code | HWL |
| Date Received | 2006-02-10 |
| Model Number | * |
| Catalog Number | 140013 |
| Lot Number | B077 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 665292 |
| Manufacturer | NEWDEAL S.A. |
| Manufacturer Address | * LYON FR |
| Baseline Brand Name | KALIX FLAT FOOT IMPLANT EXTERNAL DIAM.13MM |
| Baseline Generic Name | KALIX IMPLANT SYSTEM |
| Baseline Model No | * |
| Baseline Catalog No | 140013 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-02-10 |