MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-20 for AXOR II 1288 manufactured by Integrum Ab.
[117855258]
Manufacturing batch documentation investigation shows no deviation. The device has been manufactured according to specifications. Tha device has been in use for approx 10 months. A capa is ongoing to find root cause of the problem. [(b)(4)].
Patient Sequence No: 1, Text Type: N, H10
[117855259]
Mail: the axor ii device dislodged from the abutment, causing the external prosthesis to fall off. The patient, who was walking in a retail store at the time, fell and sustained bruising. The patient informed us of this incident today. (b)(4) has already informed (b)(4) who is working on supplying the patient with a loaner unit. (b)(4) instructed the patient not to use her current axor unit. She will remain on crutches. Adverse report from clinician. The patient called to state that the axor failsafe component disassociated from the abutment, the prosthesis fell off, and she fell to the ground while walking in a store. She states that she bruised herself badly. Over the past week, she had experienced axor loosening despite her best attempts.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011386779-2018-00007 |
| MDR Report Key | 7796960 |
| Date Received | 2018-08-20 |
| Date of Report | 2018-08-19 |
| Date of Event | 2018-07-18 |
| Date Facility Aware | 2018-07-18 |
| Report Date | 2018-07-18 |
| Date Reported to Mfgr | 2018-07-18 |
| Date Mfgr Received | 2018-07-18 |
| Device Manufacturer Date | 2017-04-07 |
| Date Added to Maude | 2018-08-20 |
| 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 | KROKSLA]TTS FABRIKER 50 |
| Manufacturer City | MOLNDAL, 43137 |
| Manufacturer Country | SW |
| Manufacturer Postal | 43137 |
| Manufacturer G1 | INTEGRUM AB |
| Manufacturer Street | KROKSLATTS FABRIKER 50 |
| Manufacturer City | MOLNDAL, V 43137 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 43137 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | AXOR II |
| Generic Name | OPRA IMPLANT SYSTEM |
| Product Code | PJY |
| Date Received | 2018-08-20 |
| Returned To Mfg | 2018-10-01 |
| Model Number | 1288 |
| Catalog Number | 1288 |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 15 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRUM AB |
| Manufacturer Address | KROKSL?TTS FABRIKER 50 M?LNDAL, GOTHENBURG 43137 SW 43137 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-20 |