MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-11-14 for OPRA FIXTURE 1348 manufactured by Integrum Ab.
[127203180]
Fixture loosening. No deviation in batch documentation. Device has been manufactured according to specifications. According to report form the cause of failure is unknown. Blood and tissue samples were taking during the extraction procedure to evaluate the possible presence of deep infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011386779-2018-00016 |
| MDR Report Key | 8071726 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-11-14 |
| Date of Report | 2018-11-21 |
| Date of Event | 2018-10-01 |
| Date Facility Aware | 2018-10-08 |
| Report Date | 2018-10-08 |
| Date Reported to Mfgr | 2018-10-08 |
| Date Mfgr Received | 2018-10-08 |
| Device Manufacturer Date | 2014-05-30 |
| Date Added to Maude | 2018-11-14 |
| 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 FIXTURE |
| Generic Name | FIXTURE BIOHELIX 22X80 |
| Product Code | PJY |
| Date Received | 2018-11-14 |
| Model Number | 1348 |
| Catalog Number | 1348 |
| Lot Number | P243445 |
| Device Expiration Date | 2019-05-01 |
| Device Availability | N |
| Device Age | 42 MO |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-11-14 |