MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-04-18 for OPRA IMPLANT SYSTEM IBC0015 manufactured by Integrum Ab.
[105840609]
Manufacturing batch documentation reviewed and no deviations found. The product is manufactured according to specifications.
Patient Sequence No: 1, Text Type: N, H10
[105840610]
Report from ucsf 22 march 2018: study subject developed increased pain, associated with elevated inflammatory markers and an abnormal pet-ct-scan on (b)(6) 2018, at which time the fixture was noted to be loose. Cultures grew (b)(6). Pathology was consistent with osteomyelitis. Intra-operatively, the fixture was removed and the bone debrided. The patient has been placed on intravenous antibiotics.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011386779-2018-00002 |
| MDR Report Key | 7441059 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-04-18 |
| Date of Report | 2018-04-16 |
| Date of Event | 2018-03-08 |
| Report Date | 2018-03-22 |
| Date Reported to Mfgr | 2018-03-22 |
| Date Mfgr Received | 2018-03-22 |
| Date Added to Maude | 2018-04-18 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. NIKLAS HOFVERBERG |
| Manufacturer Street | KROKSL |
| Manufacturer City | MOLNDAL, 43137 |
| Manufacturer Country | SW |
| Manufacturer Postal | 43137 |
| Manufacturer G1 | INTEGRUM AB |
| Manufacturer Street | KROKSL |
| Manufacturer City | MOLNDAL, 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 | OPRA IMPLANT SYSTEM |
| Product Code | PJY |
| Date Received | 2018-04-18 |
| Model Number | IBC0015 |
| Catalog Number | IBC0015 |
| Lot Number | P240890 |
| Device Expiration Date | 2019-02-01 |
| Device Availability | * |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRUM AB |
| Manufacturer Address | KROKSL?TTS FABRIKER 50 MOLNDAL, MOLNDAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-04-18 |