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 2020-02-27 for STABILIT MX.STABILIT?.STABILIT? MX FRACTURE KIT MX-1100L-01 MX-1100L-01/B manufactured by Merit Medical Ireland Ltd.
[186541813]
The suspect device is not expected to return for evaluation but a lot number was provided. A follow up will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[186541814]
The account alleges that post-kyphoplasty procedure, the steerable vertebral augmentation system became stuck within the patient spine during removal. It was noted that only the tip of the vertebral augmentation device had detached within the patient's pedicle. No chance of migration or patient injury. The procedure was completed successfully. The patient tolerated the procedure well and was discharged to home as expected. No plans to remove the foreign body.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616662-2020-00002 |
| MDR Report Key | 9767423 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-27 |
| Date of Report | 2020-01-31 |
| Date of Event | 2020-01-31 |
| Date Mfgr Received | 2020-01-31 |
| Device Manufacturer Date | 2018-08-24 |
| Date Added to Maude | 2020-02-27 |
| 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 | MR. DAVID LOCKRIDGE |
| Manufacturer Street | 1600 MERIT PARKWAY |
| Manufacturer City | SOUTH JORDAN, UT |
| Manufacturer Country | US |
| Manufacturer Phone | 2084551 |
| Manufacturer G1 | MERIT MEDICAL IRELAND LTD |
| Manufacturer Street | PARKMORE BUSINESS PARK WEST BALLYBRIT |
| Manufacturer City | GALWAY, |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STABILIT MX.STABILIT?.STABILIT? MX FRACTURE KIT |
| Generic Name | VERTEBROPLASTY KIT |
| Product Code | NDN |
| Date Received | 2020-02-27 |
| Model Number | MX-1100L-01 |
| Catalog Number | MX-1100L-01/B |
| Lot Number | K1398056 |
| Device Expiration Date | 2020-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERIT MEDICAL IRELAND LTD |
| Manufacturer Address | PARKMORE BUSINESS PARK WEST BALLYBRIT GALWAY, EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-27 |