MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-04-05 for FIREFLY FF-101-XX FF-PSG-0001 manufactured by Mighty Oak Medical.
[141077269]
Review of dhr did not find any deviations or abnormalities. Review of complaint history did not identify any additional complaints on this item for breaches resulting in revision. Review of returned product determined that the returned product was within specifications. The final root cause determination was identified to be user error in placement of the guide. This root cause was concluded based on discussions with the surgeon using the guide, bone model and post-op ct scan. No further actions are required.
Patient Sequence No: 1, Text Type: N, H10
[141077270]
It was reported that during the patients initial posterior spinal fusion operation using firefly patient-specific pedicle screw guide, while using the l4 guide on the l4 level in the patient, the left screw was placed laterally and the right screw was placed medially. Furthermore, the patient presented with pain and radiculopathy two weeks post-op and required a revision procedure to reposition these screws.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011818499-2019-00001 |
| MDR Report Key | 8488010 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-04-05 |
| Date of Report | 2019-03-28 |
| Date of Event | 2018-12-20 |
| Date Facility Aware | 2019-03-04 |
| Date Mfgr Received | 2019-03-04 |
| Device Manufacturer Date | 2018-12-14 |
| Date Added to Maude | 2019-04-05 |
| 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 | MR. MARK WYLIE |
| Manufacturer Street | 750 W HAMPDEN AVE. SUITE 120 |
| Manufacturer City | ENGLEWOOD CO 80110 |
| Manufacturer Country | US |
| Manufacturer Postal | 80110 |
| Manufacturer Phone | 7203989703 |
| Manufacturer G1 | MIGHTY OAK MEDICAL |
| Manufacturer Street | 750 W HAMPDEN AVE. SUITE 120 |
| Manufacturer City | ENGLEWOOD CO 80110 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80110 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FIREFLY |
| Generic Name | PATIENT-SPECIFIC PEDICLE SCREW GUIDE |
| Product Code | PQC |
| Date Received | 2019-04-05 |
| Returned To Mfg | 2019-03-26 |
| Model Number | FF-101-XX |
| Catalog Number | FF-PSG-0001 |
| Lot Number | 18PAHK |
| Device Expiration Date | 2019-06-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIGHTY OAK MEDICAL |
| Manufacturer Address | 750 W. HAMPDEN AVE SUITE 120 ENGLEWOOD CO 80110 US 80110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-05 |