MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-10 for RESPONSE BANDLOC SPINAL FIXATION 10-1102-1555 manufactured by Orthopediatrics, Corp.
| Report Number | 3006460162-2019-00094 |
| MDR Report Key | 9690263 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-10 |
| Date of Report | 2019-02-10 |
| Date of Event | 2019-06-14 |
| Date Mfgr Received | 2019-06-23 |
| Device Manufacturer Date | 2018-09-25 |
| Date Added to Maude | 2020-02-10 |
| 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. KRISS ANDERSON |
| Manufacturer Street | 2850 FRONTIER DR |
| Manufacturer City | WARSAW, IN |
| Manufacturer Country | US |
| Manufacturer Phone | 2686379 |
| Manufacturer G1 | ORTHOPEDIATRICS, CORP |
| Manufacturer Street | 2850 FRONTIER DR |
| Manufacturer City | WARSAW, IN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESPONSE BANDLOC SPINAL FIXATION |
| Generic Name | BONE FIXATION CERCLAGE, SUBLAMINAR |
| Product Code | OWI |
| Date Received | 2020-02-10 |
| Model Number | 10-1102-1555 |
| Lot Number | 181675 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHOPEDIATRICS, CORP |
| Manufacturer Address | 2850 FRONTIER DR WARSAW, IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-10 |