MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-01-11 for RESPONSE SPINE 5.5/6.0 UNIAXIAL PEDICLE SCREW 6MM X 40MM N/A 00-1300-0640 manufactured by Orthopediatrics, Corp.
[97053248]
(b)(4). Customer has indicated that the product will not be returned to orthopediatrics 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
[97053249]
It has been reported that following a spinal deformity correction procedure, an x-ray taken at the one year follow-up revealed a possible fractured pedicle screw. The screw is located at the left pedicle at the t12 vertebrae. The patient presented with back pain following a collision in physical education class. Based on the computerized tomography scans and patient pain levels, a revision procedure could be performed at a later date. 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 | 3006460162-2018-00002 |
| MDR Report Key | 7183941 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-01-11 |
| Date of Report | 2018-01-11 |
| Date of Event | 2017-12-13 |
| Date Mfgr Received | 2017-12-14 |
| Date Added to Maude | 2018-01-11 |
| 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, CORP |
| 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 | RESPONSE SPINE 5.5/6.0 UNIAXIAL PEDICLE SCREW 6MM X 40MM |
| Generic Name | PEDICLE SCREW SPINAL SYSTEM |
| Product Code | OSH |
| Date Received | 2018-01-11 |
| Model Number | N/A |
| Catalog Number | 00-1300-0640 |
| Lot Number | UNKNOWN |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHOPEDIATRICS, CORP |
| Manufacturer Address | 2850 FRONTIER DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-01-11 |