MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-05 for OPRA IMPLANT SYSTEM IBC0018 manufactured by Integrum Ab.
[64270217]
The device cannot be evaluated, as it is still implanted in the patient, and it will be removed per standard protocol during the second stage surgery and examined for any problems.
Patient Sequence No: 1, Text Type: N, H10
[64270218]
Routine radiographs show backing out of graft screw, likely secondary to patient's high activity level with external socket. No treatment necessary. Patient is completely asymptomatic. Graft screw will be removed as per stage 2 protocol.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011386779-2016-00001 |
| MDR Report Key | 6226529 |
| Date Received | 2017-01-05 |
| Date of Report | 2017-01-04 |
| Date of Event | 2016-12-12 |
| Date Mfgr Received | 2016-12-12 |
| Device Manufacturer Date | 2014-08-05 |
| Date Added to Maude | 2017-01-05 |
| 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 | KROKSSL |
| Manufacturer City | MOLNDAL, SE-431 37 |
| Manufacturer Country | SW |
| Manufacturer Postal | SE-431 37 |
| Manufacturer Phone | 31 760 10 |
| Manufacturer G1 | INTEGRUM AB |
| Manufacturer Street | KROKSSL |
| Manufacturer City | MOLNDAL, SE-431 37 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | SE-431 37 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | OPRA IMPLANT SYSTEM |
| Generic Name | GRAFT SCREW |
| Product Code | PJY |
| Date Received | 2017-01-05 |
| Model Number | IBC0018 |
| Catalog Number | IBC0018 |
| Lot Number | P245750 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 20 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRUM AB |
| Manufacturer Address | KROKSSL?TTS FABRIKER 50 MOLNDAL, SE-431 37 SW SE-431 37 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-05 |