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 2020-03-27 for SPINOUS PROCESS CLAMP 9734716 manufactured by Medtronic Navigation, Inc.
[185252654]
Device evaluation has not been done at the time of submitting this report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185252655]
Medtronic received information regarding a navigation system used during a sacroiliac and thoracolumbar procedure. It was reported that the spinous process clamp moved. They were working on the last level, l5, and noticed that the clamp had moved. They checked their accuracy and decided to finish the case with a c-arm. Troubleshooting was done by the clinical specialist (cs) that was onsite and there were no issues with the clamp remaining engaged. It was believed that it was attached to soft tissue that allowed it to shift. There was a procedure delay of less than one hour and no impact to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723170-2020-01092 |
| MDR Report Key | 9889286 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-03-09 |
| Date Mfgr Received | 2020-03-09 |
| Date Added to Maude | 2020-03-27 |
| 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 | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635260594 |
| Manufacturer G1 | MEDTRONIC NAVIGATION, INC |
| Manufacturer Street | 826 COAL CREEK CIRCLE |
| Manufacturer City | LOUISVILLE CO 80027 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80027 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPINOUS PROCESS CLAMP |
| Generic Name | ORTHOPEDIC STEREOTAXIC INSTRUMENT |
| Product Code | OLO |
| Date Received | 2020-03-27 |
| Model Number | 9734716 |
| Catalog Number | 9734716 |
| Lot Number | 170425 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NAVIGATION, INC |
| Manufacturer Address | 826 COAL CREEK CIRCLE LOUISVILLE CO 80027 US 80027 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |