MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-11-07 for OPRA IMPLANT SYSTEM IBC0015 manufactured by Integrum Ab.
[91225240]
Study subject was experiencing increasing left thigh pain in the femur around the surgical site. This was concerning for possible osteomyelitis. Study patient returned to (b)(6) clinic to be evaluated further by pi on (b)(6). C-reactive protein, complete blood count with differential, sedimentation rate and interleukin-6 labs were ordered to rule out possible infection on (b)(6) and final lab results were available (b)(6). These came back with abnormal levels and the patient was brought back to clinic (b)(6) to discuss results and treatment plan. The plan discussed for patient was to return for a deep cultures, possible bone biopsy, and discharge on ciprofloxacin and rifampin, for 3 to 6 months dependent on cultures grown. The study patient expressed understanding and will undergo treatment as stated. The patient is roughly 3 months into the course of treatment and has shown significant signs of improvement (i. E no longer experiencing deep pain, and normal levels of c-reactive protein and sedimentation rate).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011386779-2017-00002 |
| MDR Report Key | 7005868 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-11-07 |
| Date of Report | 2018-09-04 |
| Date of Event | 2017-08-16 |
| Date Facility Aware | 2017-10-18 |
| Report Date | 2017-10-18 |
| Date Reported to Mfgr | 2017-10-18 |
| Date Mfgr Received | 2017-10-18 |
| Device Manufacturer Date | 2014-02-14 |
| Date Added to Maude | 2017-11-07 |
| 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 | MEDICAL ASSISTANT |
| 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 | OPRA IMPLANT SYSTEM |
| Product Code | PJY |
| Date Received | 2017-11-07 |
| Model Number | IBC0015 |
| Catalog Number | IBC0015 |
| Lot Number | P240890 |
| Device Expiration Date | 2019-02-28 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRUM AB |
| Manufacturer Address | KROKSL?TTS FABRIKER 50 M?LNDAL 41270 US 41270 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-07 |