MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-09-16 for RESPONSE 5.5 SPINE SYSTEM 00-1003-4001 manufactured by Orthopediatrics Corp..
[54993163]
Revision surgery performed (b)(6) 2016 to reattach rod/pedicle screws. Outcome positive.
Patient Sequence No: 1, Text Type: N, H10
[54993164]
Distal two set screws on left spine rod and single most distal set screw on right of spine rod of construct disassociated from pedicle screw. Discovered on routine post surgical follow up visit x-rays.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006460162-2016-00005 |
| MDR Report Key | 5957118 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-09-16 |
| Date of Report | 2016-08-09 |
| Date of Event | 2016-07-08 |
| Date Mfgr Received | 2016-08-09 |
| Date Added to Maude | 2016-09-16 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MARK FOX |
| Manufacturer Street | 2850 FRONTIER DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5742686379 |
| 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 5.5 SPINE SYSTEM |
| Generic Name | PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS |
| Product Code | OSH |
| Date Received | 2016-09-16 |
| Returned To Mfg | 2016-09-15 |
| Catalog Number | 00-1003-4001 |
| 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 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-09-16 |