MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-03-29 for RESPONSE 5.5/6.0 SPINE SYSTEM 00-1003-4001 manufactured by Orthopediatrics Corp..
[71099401]
Scheuermann's kyphosis case done (b)(6) 2016. Used all poly screws and 6. 0 cobalt chrome rods. Patient came back for 1 year follow up, and bottom 3 screws on both sides became disengaged. At time of revision surgery, sales rep noted that surgeon stated that he had used the wrong instrument (jimmy device) to actually reduce rod into pedicle screws, so therefore they were not tightened as he had thought.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006460162-2017-00005 |
| MDR Report Key | 6441955 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-03-29 |
| Date of Report | 2017-01-15 |
| Date of Event | 2017-03-02 |
| Date Mfgr Received | 2017-01-15 |
| Date Added to Maude | 2017-03-29 |
| 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 |
| Removal Correction Number | SEE H10 |
| 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 | 2017-03-29 |
| Catalog Number | 00-1003-4001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-03-29 |