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 2019-06-19 for TITANIUM CONDYLAR HEAD 04.449.000S manufactured by Oberdorf Synthes Produktions Gmbh.
Report Number | 8030965-2019-65480 |
MDR Report Key | 8713321 |
Report Source | COMPANY REPRESENTATIVE,FOREIG |
Date Received | 2019-06-19 |
Date of Report | 2019-05-23 |
Date of Event | 2019-05-23 |
Date Mfgr Received | 2019-08-12 |
Device Manufacturer Date | 2018-11-12 |
Date Added to Maude | 2019-06-19 |
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 | KARA DITTY-BOVARD |
Manufacturer Street | 1302 WRIGHTS LANE EAST |
Manufacturer City | WEST CHESTER PA 19380 |
Manufacturer Country | US |
Manufacturer Postal | 19380 |
Manufacturer Phone | 6103142063 |
Manufacturer G1 | SYNTHES SELZACH |
Manufacturer Street | BOHACKERWEG 5 |
Manufacturer City | SELZACH 2545 |
Manufacturer Country | SZ |
Manufacturer Postal Code | 2545 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | TITANIUM CONDYLAR HEAD |
Generic Name | PROSTHESIS,CONDYLE,MANDIBULAR TEMPORARY |
Product Code | NEI |
Date Received | 2019-06-19 |
Catalog Number | 04.449.000S |
Lot Number | 2L26268 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | DA |
Device Eval'ed by Mfgr | R |
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 | 2019-06-19 |