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 2018-09-07 for TI MATRIXNEURO SCREW SELF-DRILLING 4MM 04.503.104.01S manufactured by Oberdorf Synthes Produktions Gmbh.
[119571856]
Patient information is unknown. Additional procodes: gxr, jey. Lot number is unknown. Device malfunctioned intra-operatively and was not implanted / explanted. Reporter email address is unknown. The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. 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
[119571857]
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that during the surgery on (b)(6) 2018, the screw driver was not able to be hold the screw. The surgery was finished without any other problem, although it was not reported how the surgery was completed. There was no surgical delay and there was no adverse consequence to the patient. This report is for a titanium (ti) matrixneuro screw self-drilling 4mm. This is report 1 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2018-56177 |
| MDR Report Key | 7855685 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-09-07 |
| Date of Report | 2018-08-15 |
| Date of Event | 2018-08-15 |
| Date Mfgr Received | 2018-09-21 |
| Date Added to Maude | 2018-09-07 |
| 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 | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHT LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | WERK BETTLACH (CH) |
| Manufacturer Street | MURACHERSTRASSE 3 |
| Manufacturer City | BETTLACH 2544 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 2544 |
| 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 | 2018-09-07 |
| Returned To Mfg | 2018-09-03 |
| Catalog Number | 04.503.104.01S |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-09-07 |