MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-11-11 for * NOT AVAILABLE 140010 manufactured by Wright Medical Technology, Inc..
[342976]
Implant failure - broke apart.
Patient Sequence No: 1, Text Type: D, B5
[370003]
Add'l info rec'd from mfr 3/15/05: mfr has received letter dated jan. 2005, regarding the new deal kalix screw, catalog #140010nd, lot #b085. This product is not manufactured by wright medical technology, inc. New deal is the manufacturer and has agreed to forward this matter to the appropriate dept.
Patient Sequence No: 1, Text Type: D, B5
[17114760]
A fda letter, report number mw1033808, dated 1/26/2005 was received to integra lifesciences complaint office on 4/26/2005. Wright medical forwarded the letter to newdeal. This letter was originally sent to wright medical technology, inc. The former distributor of newdeal product in the us. Integra lifesciences has acquired newdeal. Initial incident information was sent to wright medical technology by the user facility. Wright medical technology did not regard the complaint as a medical device reportable event, however, integra lifesciences as the new manufacturer representative of newdeal considered the complaint mdr reportable, and filed a mdr to fda. The mdr number was 9615741-2005-00004. The catalog number is 140010. The lot number is b085. The device was not available for investigation. The root cause could not be determined. A device history record review was conducted and no anomaly was found. Device was released within specification.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1033808 |
| MDR Report Key | 562733 |
| Date Received | 2004-11-11 |
| Date of Report | 2004-11-11 |
| Date of Event | 2004-10-07 |
| Date Added to Maude | 2005-01-04 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | SUB TAYLOR ARTHROTHESIS |
| Product Code | HWL |
| Date Received | 2004-11-11 |
| Returned To Mfg | 2004-10-07 |
| Model Number | NOT AVAILABLE |
| Catalog Number | 140010 |
| Lot Number | B085 |
| ID Number | NOT AVAILABLE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 583502 |
| Manufacturer | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Address | 5677 AIRLINE ROAD ARLINGTON TN 38002 US |
| Baseline Brand Name | KALIX FLAT FOOT IMPLANT EXTERNAL DIAM. 10MM |
| Baseline Generic Name | KALIX IMPLANT SYSTEM |
| Baseline Model No | * |
| Baseline Catalog No | 140010 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-11-11 |