MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-04-30 for MYSPINE MYSPINE DRILL PILOT GUIDE L05 7.0555 manufactured by Medacta International Sa.
[143583785]
Clinical evaluation performed bx medical affairs director: in an l5-s1 fusion case with pedicle screws, the surgeons reportedly expressed the feeling during surgery that the position of the left l5 screw was not optimal, then he saw the images and accepted it. The post-op ct, which we cannot access today, revealed instead that one of the screws was in the joint (according to report). We did not see screws in the joint (ct not available, just intraoperative fluoroscopies). This report is in contrast with the assertion that the screw had not violated the pedicle. From the report of the department who made the individual guides, no useful information can be gathered. The possibility that the guide was not placed in the same position as planned is always present. We cannot draw any final conclusion as to the root cause for this inconvenience. Evaluation of the case provided byy r&d spine director: looking on the x-ray provided it doesn't look like a significant off-set to the planned position. The surgeon confirmed as well that while he used the feeler probe he felt he was inside the pedicle. The s1 screws look to me very long/protrude on the anterior side. In addition to that, i don't see any screw inside the joint/disc. However, there could be a potential risk of facet joint irritation taking the tulip into account in combination with the panned entry point. Analysis performed by (b)(4) department: each step of the myspine process has been analyzed with the conclusion: 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. L05 guide was designed according to the trajectory of the screws in the planning validated (rev. 1). Conclusions: our analysis of the myspine process of this case found no deviations from the standard procedures. Each step has been performed correctly. Batch review performed on 29 apr 2019: lot 01434s: 4 items manufactured and released on 20-mar-2019. Expiration date: 2019-09-13. No anomalies found related to the problem.
Patient Sequence No: 1, Text Type: N, H10
[143583786]
Problems with the setting of the guides l5 and s1. The surgeon put the l5 guide on the vertebra and prepared the hole. He checked it on x-ray and it looked good, but when he has to insert the screws, the left screw looked very medial (not how he planned it). He took the screw out and used the tip feeler to check if he is outside the pedicle, but he wasn? T. He tried to get a better angle while inserting the screw freehand. The screw followed the previous direction and the surgeon decided to accept the result and finished the surgery. After checking the post-operation ct-scan the surgeon decided to do a revision on (b)(6) 2019, after one month from the primary, because the screw was in the joint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005180920-2019-00324 |
| MDR Report Key | 8564994 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-04-30 |
| Date of Report | 2019-04-30 |
| Date of Event | 2019-03-28 |
| Date Mfgr Received | 2019-04-01 |
| Device Manufacturer Date | 2019-03-20 |
| Date Added to Maude | 2019-04-30 |
| 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 | 3 |
| Brand Name | MYSPINE MYSPINE DRILL PILOT GUIDE L05 |
| Generic Name | PEDICLE SCREW DRILL PILOT GUIDE |
| Product Code | PQC |
| Date Received | 2019-04-30 |
| Catalog Number | 7.0555 |
| Lot Number | 01434S |
| Device Expiration Date | 2019-09-13 |
| 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. Required No Informationntervention | 2019-04-30 |