MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-30 for VITALITY? 730M0024 manufactured by Biomet Spine Llc.
[185502327]
An implant was put in the patient's back. The implant broke in the patient. The broken implant was taken out along with the other broken pieces. Xray was taken after to make sure there were no more broken pieces left in the pt. Xrays taken. Broken implant was checked by (b)(4) rep, who clarified that all pieces were there.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9897082 |
| MDR Report Key | 9897082 |
| Date Received | 2020-03-30 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-02-12 |
| Report Date | 2020-03-02 |
| Date Reported to FDA | 2020-03-02 |
| Date Reported to Mfgr | 2020-03-30 |
| Date Added to Maude | 2020-03-30 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITALITY? |
| Generic Name | THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM |
| Product Code | NKB |
| Date Received | 2020-03-30 |
| Model Number | 730M0024 |
| Catalog Number | 730M0024 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET SPINE LLC |
| Manufacturer Address | 56 EAST BELL DRIVE WARSAW IN 46581 US 46581 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |