MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-11-15 for TI MATRIXNEURO SCREW SELF-DRILLING 4MM 04.503.104.01C manufactured by Oberdorf Synthes Produktions Gmbh.
[127559097]
Additional product codes: jey, gxr. (b)(6). Initial reporter is synthes sales consultant. Without a lot number the device history records review could not be completed. 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
[127559098]
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that during an unknown surgical procedure on an unknown date, the 4mm matrixneuro screw was inserted badly. No additional information was provided. This report is for one (1) 4mm matrixneuro screw. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2018-58273 |
| MDR Report Key | 8075956 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-11-15 |
| Date of Report | 2018-10-29 |
| Date Mfgr Received | 2018-11-20 |
| Date Added to Maude | 2018-11-15 |
| 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 |
| 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 | 1302 WRIGHT LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | MONUMENT |
| Manufacturer Street | 1101 SYNTHES AVENUE |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TI MATRIXNEURO SCREW SELF-DRILLING 4MM |
| Generic Name | PLATE,CRANIOPLASTY,PREFORMED, ALTERABLE |
| Product Code | GWO |
| Date Received | 2018-11-15 |
| Returned To Mfg | 2018-11-05 |
| Catalog Number | 04.503.104.01C |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OBERDORF SYNTHES PRODUKTIONS GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF 4436 SZ 4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-15 |