MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-09-23 for RESPONSE 5.5/6.0 SPINE SYSTEM UNKNOWN manufactured by Orthopediatrics Corp..
[55442737]
Spine rod / pedicle screw disassociated as the rod was not seated in the saddle. Towers were used and set screws appeared flush to the surgeon intraoperatively. Malfunction discovered during 9 month office follow up visit x-rays. Revision surgery completed. No patient information known. No other details after multiple attempts.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3006460162-2016-00006 |
MDR Report Key | 5972740 |
Report Source | COMPANY REPRESENTATIVE |
Date Received | 2016-09-23 |
Date of Report | 2016-08-25 |
Date of Event | 2016-08-25 |
Date Mfgr Received | 2016-08-25 |
Date Added to Maude | 2016-09-23 |
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 5.5/6.0 SPINE SYSTEM |
Generic Name | PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS |
Product Code | OSH |
Date Received | 2016-09-23 |
Catalog Number | UNKNOWN |
Lot Number | UNKNOWN |
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 | 2016-09-23 |