MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-12 for MYSPINE S01 DRILL BASED GUIDE 7.0726 manufactured by Medacta International Sa.
[130470255]
Other device involved: myspine s01 vertebra reference 7. 0706 (k173472); batch review performed on 12 december 2018; lot 00981s: (b)(4) items manufactured and released on 31 october 2018. Expiration date: 2019-03-14; no anomalies found related to the problem. Investigation performed by mysolution department on november 21, 2018. 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
[130470256]
The surgeon was not able to drill safety because the sleeve part length of myspine s01 drill based guide was too short in comparison with others. Moreover it was not able to set on the spinal bone stable. The surgeon drilled only the entry point under the imaging and proceeded freehand drilling causing a critical delay in the surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005180920-2018-00986 |
| MDR Report Key | 8155012 |
| Date Received | 2018-12-12 |
| Date of Report | 2019-01-17 |
| Date of Event | 2018-11-12 |
| Date Mfgr Received | 2018-11-12 |
| Device Manufacturer Date | 2018-10-31 |
| Date Added to Maude | 2018-12-12 |
| 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 S01 DRILL BASED GUIDE |
| Generic Name | DRILL BASED GUIDE |
| Product Code | PQC |
| Date Received | 2018-12-12 |
| Returned To Mfg | 2018-12-17 |
| Catalog Number | 7.0726 |
| Lot Number | 00981S |
| Device Expiration Date | 2019-03-14 |
| 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, SWITZERLAND 6874 SZ 6874 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-12 |