MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-06 for MYSPINE MYSPINE LP DRILL PILOT GUIDE L04 7.0554 manufactured by Medacta International Sa.
[188933600]
Batch review performed on 18 february 2020: lot 02581s: (b)(4) item manufactured and released on 23-jan-2020. No anomalies found related to the problem. Patient match planing review each step of the process have been analyzed by my solution department. We analyzed each step of the myspine process. Images qc: the images we received were subjected to quality control, the result of which was positive. Reconstruction: the reconstruction is precise and correct, all areas were clearly identifiable. Planning: the surgeon modified and validated the planning (rev. 1). Guide: the guide was designed according to the trajectory of the screws in the planning validated (rev. 1). As usual, during the guide design we checked with the upper and the lower vertebra that there was no impingement. Conclusions our analysis of the myspine process of this case found no deviations from the standard procedures. Each step has been performed correctly
Patient Sequence No: 1, Text Type: N, H10
[188933601]
It was not possible to use myspine guide l4 because there was a problem related to its settng. The patient lamina of l4/l5 were too closer, so in order to set the myspine guide l4, the patient lamina l4 should have been recected. The surgery finished without using myspine guide. 30 minutes delay and additional anesthesia has been used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005180920-2020-00131 |
| MDR Report Key | 9799371 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-06 |
| Date of Report | 2020-02-06 |
| Date of Event | 2020-02-06 |
| Date Mfgr Received | 2020-02-06 |
| Device Manufacturer Date | 2020-01-23 |
| Date Added to Maude | 2020-03-06 |
| 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 STEFANO BAJ |
| Manufacturer Street | STRADA REGINA |
| Manufacturer City | CASTEL SAN PIETRO, SWITZERLAND 6874 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 6874 |
| Manufacturer G1 | MEDACTA INTERNATIONAL SA |
| Manufacturer Street | STRADA REGINA |
| Manufacturer City | CASTEL SAN PIETRO, 6874 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 6874 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MYSPINE MYSPINE LP DRILL PILOT GUIDE L04 |
| Generic Name | DRILL PILOT GUIDE |
| Product Code | MNI |
| Date Received | 2020-03-06 |
| Catalog Number | 7.0554 |
| Lot Number | 02581S |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDACTA INTERNATIONAL SA |
| Manufacturer Address | STRADA REGINA CASTEL SAN PIETRO, 6874 SZ 6874 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-06 |