MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-04-02 for KALIX FLAT FOOT IMPLANT EXTERNAL DIAM. 11MM * 140011 manufactured by Newdeal S.a..
[18108330]
During a surgery, the physician placed a kalix i implant (size 11). The implant is locked, but the physician did not feel that it was well-implanted. So , the physician wanted to re-impact the implant. The titanium portion was unscrewed from the polyethylene portion. The implant was repositioned. When the titanium portion was inserted back into the polyethylene portion, it slipped through. The polyethylene part had expanded and the titanium could not be re-fitted or screwed back in to the polyethylene. The polyethylene part was taken out through the previous incision. The physician had to cut another little incision (on the internal face) to remove the titanium part from the patient. The physician successfully placed another implant (bigger size, size 12). The surgery time has been increased less than 10 minutes.
Patient Sequence No: 1, Text Type: D, B5
[18389095]
The product was not returned for evaluation. The user facility provided the lot number. A review of the device history record was conducted and found no anomalies during the manufacturing process. The complaints database were reviewed. Since 2000, nine complaints were received for this product, concerning the elements coming apart. Based upon the reported incident and due to the lack of product return, the exact root cause could not be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615741-2007-00016 |
| MDR Report Key | 834768 |
| Report Source | 07 |
| Date Received | 2007-04-02 |
| Date of Report | 2007-04-02 |
| Date of Event | 2006-04-10 |
| Date Mfgr Received | 2006-04-13 |
| Date Added to Maude | 2007-04-09 |
| 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 | DANIEL-GARY HOLDERMAN |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362469 |
| 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 | 2007-04-02 |
| Model Number | * |
| Catalog Number | 140011 |
| Lot Number | E01C |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 822091 |
| Manufacturer | NEWDEAL S.A. |
| Manufacturer Address | * LYON FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-04-02 |