MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-08 for TRUE LOK PLUS SYSTEM 54-11230 manufactured by Orthofix Srl.
[144534715]
Information provided states that appx. 2 1/2 weeks post op the patient was weight bearing with a rocker rail attached to the frame. Two of the three half pins that were applied sheared. The 5mm half pin broke 1/2 cm from the fixation bolt and was removed. The 4mm half pin broke at the skin and was left in the patient. The frame remains on the patient and will be removed after completion of treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183449-2019-00005 |
| MDR Report Key | 8593735 |
| Date Received | 2019-05-08 |
| Date of Report | 2019-05-06 |
| Date Facility Aware | 2019-04-09 |
| Report Date | 2019-04-09 |
| Date Reported to Mfgr | 2019-04-09 |
| Date Added to Maude | 2019-05-08 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRUE LOK PLUS SYSTEM |
| Generic Name | HALF PIN |
| Product Code | LXT |
| Date Received | 2019-05-08 |
| Model Number | 54-11230 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHOFIX SRL |
| Manufacturer Address | VIA DELLE NAZIONI 9 BUSSOLENGO, VERONA 37012 IT 37012 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-08 |