MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2019-09-12 for OSTEOSET UNK manufactured by Wright Medical Technology, Inc..
Report Number | 1043534-2019-00144 |
MDR Report Key | 9012740 |
Report Source | HEALTH PROFESSIONAL,LITERATUR |
Date Received | 2019-09-12 |
Date of Report | 2019-08-16 |
Date of Event | 2012-03-07 |
Date Mfgr Received | 2019-08-16 |
Date Added to Maude | 2019-09-12 |
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 MATTHEW PARRISH |
Manufacturer Street | 1023 CHERRY RD |
Manufacturer City | MEMPHIS TN 38117 |
Manufacturer Country | US |
Manufacturer Postal | 38117 |
Manufacturer G1 | WRIGHT MEDICAL TECHNOLOGY, INC. |
Manufacturer Street | 11576 MEMPHIS ARLINGTON RD |
Manufacturer City | ARLINGTON TN 38002 |
Manufacturer Country | US |
Manufacturer Postal Code | 38002 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | OSTEOSET |
Generic Name | FILLER, BONE VOID, CALCIUM COMPOUND |
Product Code | MQV |
Date Received | 2019-09-12 |
Model Number | UNK |
Lot Number | UNK |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | WRIGHT MEDICAL TECHNOLOGY, INC. |
Manufacturer Address | 11576 MEMPHIS ARLINGTON RD ARLINGTON TN 38002 US 38002 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2019-09-12 |