MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2020-02-23 for RESPONSE SPINE 5.5, SET SCREW, SMALL N/A 00-1003-3012 manufactured by Orthopediatrics, Inc.
Report Number | 3006460162-2019-00041 |
MDR Report Key | 9742964 |
Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
Date Received | 2020-02-23 |
Date of Report | 2019-08-02 |
Date Mfgr Received | 2019-07-04 |
Date Added to Maude | 2020-02-23 |
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 | LEIGH JESSOP |
Manufacturer Street | 2850 FRONTIER DRIVE |
Manufacturer City | WARSAW, IN |
Manufacturer Country | US |
Manufacturer Phone | 2670872 |
Manufacturer G1 | ORTHOPEDIATRICS, INC |
Manufacturer Street | 2850 FRONTIER DRIVE |
Manufacturer City | WARSAW, IN |
Manufacturer Country | US |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | RESPONSE SPINE 5.5, SET SCREW, SMALL |
Generic Name | PEDICLE SCREW SPINAL SYSTEM |
Product Code | OSH |
Date Received | 2020-02-23 |
Model Number | N/A |
Catalog Number | 00-1003-3012 |
Lot Number | UNKNOWN |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | ORTHOPEDIATRICS, INC |
Manufacturer Address | 2850 FRONTIER DRIVE WARSAW, IN US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Deathisabilit | 2020-02-23 |