MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-30 for SYMPHONY OCT SYSTEM POLYAXIAL SCREW DRIVER RETENTION SLEEVE 2020-00-401 202000401 manufactured by Medos International Sàrl Ch.
[177174542]
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[177174543]
It was reported that on (b)(6) 2019, that the screwdriver was sticking. Surgical delay is unknown. Procedure and patient outcome are unknown. This report is for one (1) symphony oct system polyaxial screw driver retention sleeve. This is report 3 of 3 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2020-00460 |
| MDR Report Key | 9646838 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-30 |
| Date of Report | 2019-12-06 |
| Date of Event | 2019-12-03 |
| Date Mfgr Received | 2020-01-30 |
| Device Manufacturer Date | 2019-10-31 |
| Date Added to Maude | 2020-01-30 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | CHEMIN-BLANC 38 |
| Manufacturer City | LE LOCLE 02400 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 02400 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | DEPUY SPINE INC |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYMPHONY OCT SYSTEM POLYAXIAL SCREW DRIVER RETENTION SLEEVE |
| Generic Name | CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY |
| Product Code | GEA |
| Date Received | 2020-01-30 |
| Returned To Mfg | 2019-12-18 |
| Model Number | 2020-00-401 |
| Catalog Number | 202000401 |
| Lot Number | PC4907029 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDOS INTERNATIONAL SàRL CH |
| Manufacturer Address | CHEMIN-BLANC 38 LE LOCLE 02400 SZ 02400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-30 |