MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-12 for TRUELOK 54-1215 manufactured by Orthofix Srl.
[183428103]
Information provided states that on (b)(6) 2019 the patient had a truelok frame placed on right foot and ankle. The patient returned to clinic approximately 2 weeks after surgery for post op follow-up. It was noticed at that time that a strut and two pins had broken. A revision surgery was performed to replace the pins and strut. All pieces of the pins were successfully removed from the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183449-2019-00008 |
| MDR Report Key | 9312523 |
| Date Received | 2019-11-12 |
| Date of Report | 2019-11-06 |
| Date of Event | 2019-10-01 |
| Date Facility Aware | 2019-10-14 |
| Report Date | 2019-10-07 |
| Date Reported to Mfgr | 2019-10-07 |
| Date Added to Maude | 2019-11-12 |
| 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 | 0 |
| Brand Name | TRUELOK |
| Generic Name | TL, WIRE |
| Product Code | LXT |
| Date Received | 2019-11-12 |
| Model Number | 54-1215 |
| 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, 37012 IT 37012 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-11-12 |