MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2005-03-31 for KALIX FLAT FOOT IMPLANT EXTERNAL DIAM.9MM * 140009 manufactured by Newdeal S.a..
[369496]
Distributor reported that upon inserting implant to the patient, the device broke into two pieces to the screw and the device body fell and broke on the operation room floor. Another device was available to complete the procedure. There w3as no surgical delay nor patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615741-2005-00001 |
| MDR Report Key | 587605 |
| Report Source | 08 |
| Date Received | 2005-03-31 |
| Date of Report | 2005-03-31 |
| Date Mfgr Received | 2005-03-01 |
| Date Added to Maude | 2005-04-05 |
| 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 | NEW DEAL S.A |
| Manufacturer Street | 10 PLACE D'HELVETIE |
| Manufacturer City | LYON 696006 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 696006 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KALIX FLAT FOOT IMPLANT EXTERNAL DIAM.9MM |
| Generic Name | KALIX FLAT FOOL IMPLANT SYSTEM |
| Product Code | ISH |
| Date Received | 2005-03-31 |
| Model Number | * |
| Catalog Number | 140009 |
| Lot Number | B093 |
| 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 | 577452 |
| Manufacturer | NEWDEAL S.A. |
| Manufacturer Address | * LYON FR |
| Baseline Brand Name | KALIX FLAT FOOT IMPLANT EXTERNAL DIAM.9MM |
| Baseline Generic Name | KALIX FLAT FOOL IMPLANT SYSTEM |
| Baseline Model No | * |
| Baseline Catalog No | 140009 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-03-31 |