MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-09-06 for RESPONSE 5.5 SPINE SYSTEM 00-1003-4001 manufactured by Orthopediatrics Corp..
[53995793]
Surgeon informed manufacturer that the set screw on the left side (most distal) was probably cross threaded. The 6-month follow up x-rays show that the rod had slipped in the axially direction and the surgeon confirmed this in the revision surgery. Additionally, the next level up on the left side from the most distal screw also showed slip along the rod. The surgeon also noted slippage on the same two most distal screws on the right side. The surgeon stated he was unsure if he used the correct torque limiter upon final tightening. Device not returned for evaluation
Patient Sequence No: 1, Text Type: N, H10
[53995794]
Both cocr rods found to be disassociated from the distal pedicle screws in construct, via x-ray at 6-month follow up.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006460162-2016-00001 |
| MDR Report Key | 5930751 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-09-06 |
| Date of Report | 2016-06-29 |
| Date Mfgr Received | 2016-01-22 |
| Date Added to Maude | 2016-09-06 |
| 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 |
| Product Code | OSH |
| Date Received | 2016-09-06 |
| Catalog Number | 00-1003-4001 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2016-09-06 |