MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,08 report with the FDA on 2015-01-28 for GUIDED GROWTH SYSTEM EIGHT PLATE, QUAD-PLATE GP224CE manufactured by Orthofix Inc..
[5186206]
Based on the information provided, the broken 24mm 8-plate screw was observed 2. 5 years into an ankle valgus correction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008524126-2015-00001 |
| MDR Report Key | 4466546 |
| Report Source | 07,08 |
| Date Received | 2015-01-28 |
| Date of Report | 2015-01-06 |
| Date of Event | 2014-12-08 |
| Date Mfgr Received | 2014-12-08 |
| Date Added to Maude | 2015-03-04 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHENOA WILLIAMS |
| Manufacturer Street | 3451 PLANO PARKWAY |
| Manufacturer City | LEWISVILLE TX 750560000 |
| Manufacturer Country | US |
| Manufacturer Postal | 750560000 |
| Manufacturer Phone | 2149372362 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GUIDED GROWTH SYSTEM EIGHT PLATE, QUAD-PLATE |
| Product Code | OBT |
| Date Received | 2015-01-28 |
| Returned To Mfg | 2014-12-31 |
| Model Number | GP224CE |
| Lot Number | M21862 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHOFIX INC. |
| Manufacturer Address | LEWISVILLE TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-01-28 |