MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-11-20 for MYSPINE S01 DRILL BASED GUIDE 7.0726 manufactured by Medacta International Sa.
[177397606]
Batch review performed on 04-nov-2019: lot 02007s: (b)(4) items manufactured and released on 17-sep-2019. No anomalies found related to the problem. Mysolution analysis: our analysis of the myspine process of this case found no deviations from the standard procedures. Each step has been performed correctly. The guide size and the position of the tubes depend on the planned trajectory.
Patient Sequence No: 1, Text Type: N, H10
[177397607]
During the primary spine surgery, while the surgeon was drilling the s1 guide holes, the surgeon observed that the s01 guide was too large for the incision made. The surgeon had to make his incision larger in order to use the s01 guide. There was a 35-minute delay in the case and no additional anaesthesia was used. The surgery was completed successfully. Case code: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005180920-2019-00975 |
| MDR Report Key | 9346918 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-11-20 |
| Date of Report | 2019-11-20 |
| Date of Event | 2019-10-23 |
| Date Mfgr Received | 2019-10-23 |
| Device Manufacturer Date | 2019-09-17 |
| Date Added to Maude | 2019-11-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 S01 DRILL BASED GUIDE |
| Generic Name | DRILL BASED GUIDE |
| Product Code | PQC |
| Date Received | 2019-11-20 |
| Catalog Number | 7.0726 |
| Lot Number | 02007S |
| 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. Other | 2019-11-20 |