MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-07 for ORTHOSENSOR VERASENSE KNEE SYSTEM SNN-JRNYBCS78-L manufactured by Orthosensor 1855 Griffin Road.
[59780009]
Product was activated then properly transferred to sterile field. Device then disconnected from the receiver, and no longer transmitted data. This was discovered while attempting to zero the device. Although troubleshooting attempts were made, the device was never again able to transmit data, and so was not inserted in the patient. The device was returned to sponsor for reimbursement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5065944 |
| MDR Report Key | 6092304 |
| Date Received | 2016-11-07 |
| Date of Report | 2016-11-07 |
| Date of Event | 2016-10-25 |
| Date Added to Maude | 2016-11-10 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ORTHOSENSOR VERASENSE KNEE SYSTEM |
| Generic Name | VERASENSE KNEE SYSTEM FOR JOURNEY II BCS |
| Product Code | ONN |
| Date Received | 2016-11-07 |
| Returned To Mfg | 2016-10-25 |
| Catalog Number | SNN-JRNYBCS78-L |
| Lot Number | 051315V12704 |
| Device Expiration Date | 2017-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHOSENSOR 1855 GRIFFIN ROAD |
| Manufacturer Address | STE A-310 DANIA BEACH FL 33004 US 33004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-07 |