MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-12-19 for OPRA IMPLANT SYSTEM 1800 manufactured by Integrum Ab.
[130983367]
Fixture loosening, deep infection. Probably cause unknown according to surgeon. At surgery a bad pressfit is discovered. Play between components with tightened abutment screw. (b)(4). The product performance will not be affected according to concession documentation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011386779-2018-00018 |
| MDR Report Key | 8182324 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-12-19 |
| Date of Report | 2019-02-12 |
| Date of Event | 2018-11-29 |
| Date Facility Aware | 2018-12-06 |
| Report Date | 2018-12-04 |
| Date Reported to Mfgr | 2018-12-04 |
| Date Mfgr Received | 2018-12-06 |
| Device Manufacturer Date | 2017-01-20 |
| Date Added to Maude | 2018-12-19 |
| 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 | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPRA IMPLANT SYSTEM |
| Generic Name | FIXTURE BIOHELIX 16X80 |
| Product Code | PJY |
| Date Received | 2018-12-19 |
| Model Number | 1800 |
| Catalog Number | 1800 |
| Lot Number | R5370 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 14 MO |
| 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 | 2018-12-19 |