MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-17 for MOTOR MR8 ELECTRIC NAVIGATED S8 EM800N manufactured by Mdt Powered Surgical Solutions.
[188934022]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188934063]
On follow-up, it was confirmed that no further information can be provided regarding the serial number of the navlock and the screw was not a medtronic product. No further information regarding the status of the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1625507-2020-00033 |
| MDR Report Key | 9844703 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date Mfgr Received | 2020-02-17 |
| Date Added to Maude | 2020-03-17 |
| 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 | STACY RUEMPING |
| Manufacturer Street | 4620 NORTH BEACH STREET |
| Manufacturer City | FT. WORTH TX 761373291 |
| Manufacturer Country | US |
| Manufacturer Postal | 761373291 |
| Manufacturer Phone | 7635260594 |
| Manufacturer G1 | MDT POWERED SURGICAL SOLUTIONS |
| Manufacturer Street | 4620 N BEACH ST |
| Manufacturer City | FORT WORTH TX 76137 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 76137 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MOTOR MR8 ELECTRIC NAVIGATED S8 |
| Generic Name | MOTOR, DRILL, PNEUMATIC |
| Product Code | HBB |
| Date Received | 2020-03-17 |
| Model Number | EM800N |
| Catalog Number | EM800N |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MDT POWERED SURGICAL SOLUTIONS |
| Manufacturer Address | 4620 N BEACH ST FORT WORTH TX 76137 US 76137 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-17 |