MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2006-03-31 for CHARLOTTE MTP FUSION PLATE 4111-0006 manufactured by Wright Medical Technology, Inc..
[441207]
Allegedly product has not been removed from pt as of today. Surgeon has no plans to do unless pt begins to have pain. The above product presented today on x-rays as broken hardware. It appears to be broken through the distal oblong screw hole. Surgeon used a 3. 00 muc screw for joint fixation which is not broken. This pt is about 6 weeks post-op.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043534-2006-00032 |
| MDR Report Key | 695366 |
| Report Source | 05,07 |
| Date Received | 2006-03-31 |
| Date of Report | 2006-03-16 |
| Date of Event | 2006-02-01 |
| Date Facility Aware | 2006-03-16 |
| Date Mfgr Received | 2006-03-16 |
| Date Added to Maude | 2006-04-05 |
| 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 | 3 |
| Manufacturer Contact | SUSAN ANDERSON |
| Manufacturer Street | 5677 AIRLINE ROAD |
| Manufacturer City | ARLINGTON TN 38002 |
| Manufacturer Country | US |
| Manufacturer Postal | 38002 |
| Manufacturer Phone | 9018674140 |
| Manufacturer G1 | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Street | 5677 AIRLINE ROAD |
| Manufacturer City | ARLINGTON TN 38002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHARLOTTE MTP FUSION PLATE |
| Generic Name | SMALL JOINT COMPONENT |
| Product Code | KIG |
| Date Received | 2006-03-31 |
| Model Number | NA |
| Catalog Number | 4111-0006 |
| Lot Number | NI |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1.5 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 684498 |
| Manufacturer | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Address | * ARLINGTON TN * US |
| Baseline Brand Name | CHARLOTTE (R) MTP FUSION PLATE |
| Baseline Generic Name | SMALL JOINT COMPONENT |
| Baseline Model No | NA |
| Baseline Catalog No | 4111-0006 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-03-31 |