MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-19 for SPINE CLAMP 9734715K manufactured by Medtronic Navigation, Inc.
[184178890]
The unique identifier was not known at the time of reporting. No parts have been received by the manufacturer for evaluation. The manufacturer date was not available at the time of reporting. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184178891]
Medtronic received information regarding a navigation system being used in a sacroiliac and thoracolumbar procedure. It was reported that the site was having issues clamping the spinous process clamp onto c2 as it was still loose after tightening. The site had to thread the screws while placing the clamp on in order to get the clamp to stay. There was a 5 min delay in the case. There was no impact on patient outcome. Additional information was received stating that the clamp would not tighten at all on the spine because of the of the clamp. The screw would not engage. They had to take it off of the spine, begin to tighten the clamp and then mallet it onto the spine and tighten it some more.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723170-2020-00974 |
| MDR Report Key | 9856789 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-03-03 |
| Date Mfgr Received | 2020-03-03 |
| Date Added to Maude | 2020-03-19 |
| 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 | 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 | SPINE CLAMP |
| Generic Name | ORTHOPEDIC STEREOTAXIC INSTRUMENT |
| Product Code | OLO |
| Date Received | 2020-03-19 |
| Model Number | 9734715K |
| Catalog Number | 9734715K |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2020-03-19 |