MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-14 for MYSPINE MYSPINE MC DRILL BASED GUIDE L04 7.0724 manufactured by Medacta International Sa.
[188227821]
Patient match planning review as per your request, 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. The reconstructed profiles follow accurately the contour of the vertebrae: planning: the surgeon validated our first planning proposal. The guides were designed according to the trajectory of the screws in the planning validated by the surgeon. Conclusions our analysis of the myspine process of this case found no deviations from the standard procedures. Each step has been performed correctly. Additional device involved: myspine 7. 0725 myspine mc drill based guide l05 (k173472) lot. 02494s. All the items involved are related to lot number 02494s batch review performed on 28 january 2019: lot 02494s: (b)(4) guides manufactured and released on 02-jan-2020. No anomalies found related to the problem.
Patient Sequence No: 1, Text Type: N, H10
[188227822]
The surgeon was not able to set the myspine mc guide correctly at l4- l5. The surgeon finished the surgery without using the myspine mc guide. Due to this event the surgery was prolonged about 1 hour. Total surgery time about 200 mins.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005180920-2020-00059 |
| MDR Report Key | 9710937 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-14 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-01-16 |
| Date Mfgr Received | 2020-01-16 |
| Device Manufacturer Date | 2020-01-02 |
| Date Added to Maude | 2020-02-14 |
| 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 MC DRILL BASED GUIDE L04 |
| Generic Name | DRILL GUIDE FOR SPINE SURGERY |
| Product Code | PQC |
| Date Received | 2020-02-14 |
| Returned To Mfg | 2020-02-18 |
| Catalog Number | 7.0724 |
| Lot Number | 02494S |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Other | 2020-02-14 |