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 2019-03-05 for 5.5/6.0 RESPONSE POLYAXIAL PEDICLE SCREW 7.0MM X 70MM N/A 00-1300-2770 manufactured by Orthopediatrics, Inc.
[139825883]
Reference: (b)(4). Customer has indicated that the product will not be returned to ortho-pediatrics for investigation as it is still implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[139825884]
It has been report that following the implantation of a response spine system, two polyaxial screws fractured. Attempts have been made and additional information on the reported event is unavailable at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006460162-2019-00007 |
| MDR Report Key | 8392476 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2019-03-05 |
| Date of Report | 2019-03-05 |
| Date Mfgr Received | 2019-02-04 |
| Date Added to Maude | 2019-03-05 |
| 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 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5742670872 |
| Manufacturer G1 | ORTHOPEDIATRICS, INC |
| Manufacturer Street | 2850 FRONTIER DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 5.5/6.0 RESPONSE POLYAXIAL PEDICLE SCREW 7.0MM X 70MM |
| Generic Name | PEDICLE SCREW SPINAL SYSTEM |
| Product Code | OSH |
| Date Received | 2019-03-05 |
| Model Number | N/A |
| Catalog Number | 00-1300-2770 |
| 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 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-05 |