MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-06 for MYSPINE MC VERTEBRA L04 7.0704 manufactured by Medacta International Sa.
[113633631]
Lot 00683s: (b)(4) items manufactured and released 11 may 2018. Expiration date: 2018-10-17 no anomalies found related to the issue. Other devices involved all of the same lot: reference 7. 0705 (k173472) myspine mc vertebra l05; reference 7. 0724 (k173472) myspine mc drill based guide l04; reference 7. 0425 (k173472) myspine mc drill based guide l05. Clinical evaluation performed by medical affairs (b)(4) on 06 july 2018: l4-l5 cbt stabilization was performed using patient specific guides. The final position of the screws is not satisfactory, and different from planning. With the elements at hand, no further conclusion can be drawn. We are unable to identify a clinical cause for the event. Investigation performed by patient match department on 06 june 2018; our analysis of the myspine process of this case found no deviations from the standard procedures. Each step has been performed correctly. On 06 july 2018 they performed a further investigation and as a result they reported: the final trajectories of the screws implanted don't reflect the planned one. The planning was modified and validated by the surgeon as said in the previous analysis. The entry points are conform to the protocol and are positioned in a flat zone.
Patient Sequence No: 1, Text Type: N, H10
[113633632]
The surgery was performed on (b)(6) with myspine mc guide. When the surgeon checked the ct image on (b)(6), he noticed that the pedicle screws were inserted in a different place in comparison with the planning. One of the pedicle screw protrudes laterally and the other one medially.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005180920-2018-00486 |
| MDR Report Key | 7666246 |
| Date Received | 2018-07-06 |
| Date of Report | 2018-07-06 |
| Date of Event | 2018-06-07 |
| Date Mfgr Received | 2018-06-07 |
| Device Manufacturer Date | 2018-05-11 |
| Date Added to Maude | 2018-07-06 |
| 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, SWITZERLAND 6874 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 6874 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MYSPINE MC VERTEBRA L04 |
| Generic Name | SURGICAL INSTRUMENT FOR SPINE |
| Product Code | PQC |
| Date Received | 2018-07-06 |
| Catalog Number | 7.0704 |
| Lot Number | 00683S |
| Device Expiration Date | 2018-10-17 |
| 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, SWITZERLAND 6874 SZ 6874 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-07-06 |