MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-08-27 for OPRA IMPLANT SYSTEM manufactured by Integrum Ab.
[118279159]
In the report from treating physician the treatment to patient given was the following: on (b)(6) 2018, dr. (b)(6) performed left hip open reduction and internal fixation on patient 1004, using a sliding hip screw and side plate.
Patient Sequence No: 1, Text Type: N, H10
[118279160]
Report from treating physician: serious adverse event report on patient 1004 who fell on (b)(6) 2018, sustaining an ipsilateral periprosthetic intertrochanteric hip fracture that required operative fixation with a sliding hip screw and side plate construct on (b)(6) 2018. On (b)(6) 2018, the patient was storing a bicycle when she stepped on a pedal with her prosthetic foot, lost her balance and fell. She had immediate left hip pain. Radiographics obtained at a local urgent care facility were confirmed to show an intertrochanteric hip fracture.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011386779-2018-00010 |
| MDR Report Key | 7817908 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-08-27 |
| Date of Report | 2018-08-26 |
| Date of Event | 2018-08-04 |
| Report Date | 2018-08-09 |
| Date Reported to Mfgr | 2018-08-09 |
| Date Mfgr Received | 2018-08-09 |
| Date Added to Maude | 2018-08-27 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. NIKLAS HOFVERBERG |
| Manufacturer Street | KROKSLATTS FABRIKER 50 |
| Manufacturer City | MOLNDAL, VASTRA GOTALAND 43137 |
| Manufacturer Country | SW |
| Manufacturer Postal | 43137 |
| Manufacturer G1 | INTEGRUM AB |
| Manufacturer Street | KROKSLATTS FABRIKER 50 |
| Manufacturer City | MOLNDAL, VASTRA GOTALAND 43137 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 43137 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | OPRA IMPLANT SYSTEM |
| Product Code | PJY |
| Date Received | 2018-08-27 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRUM AB |
| Manufacturer Address | KROKSLATTS FABRIKER 50 MOLNDAL, VASTRA GOTALAND 43137 SW 43137 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-27 |