MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2020-02-14 for RESPONSE 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 35MM N/A 00-1300-0735 manufactured by Orthopediatrics, Corp.
| Report Number | 3006460162-2020-00007 |
| MDR Report Key | 9714167 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-02-14 |
| Date of Report | 2020-01-27 |
| Date of Event | 2020-01-10 |
| Date Mfgr Received | 2020-01-10 |
| Device Manufacturer Date | 2019-08-19 |
| Date Added to Maude | 2020-02-14 |
| 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, CORP |
| 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 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 35MM |
| Generic Name | PEDICLE SCREW SPINAL SYSTEM |
| Product Code | OSH |
| Date Received | 2020-02-14 |
| Returned To Mfg | 2020-01-24 |
| Model Number | N/A |
| Catalog Number | 00-1300-0735 |
| Lot Number | 200269-L |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHOPEDIATRICS, CORP |
| Manufacturer Address | 2850 FRONTIER DRIVE WARSAW, IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-14 |