MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-03-15 for RESPONSE 5.5/6.0 SPINE SYSTEM 00-1300-4001 manufactured by Orthopediatrics Corp..
[70013992]
Surgeon advised that he had a patient come in for routine follow up and presented with pain. X-ray indicated that both of the lateral connectors have disengaged from the iliac screws at some point between the office visit and the surgery ((b)(6) 2016). Revision surgery performed on (b)(6) 2017: lateral connectors dissociated from the 2 screws at the bottom of the construct. One side was 5. 5 cocr, the other side was a 6. 0 cocr rod the initial surgery predated surgeon retraining and his use of towers at the bottom of the construct. Removed 2 screws that were spanning the si joint. Removed all set screws and rods from the construct. Left the pedicle screws in place. Added 2 7 x 25 poly screws in s1 and 28 x 80 poly screws in s2 replaced the original rods with 5. 5 titanium rods. Utilized towers at bottom of the construct and most other pedicle screws. Jiminys used to help reduce the rod and towers for final reduction. Used 95inlb torque drivers to set the screws. Utilized a fixed t-handle to provide additional torque to the set screws.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006460162-2017-00314 |
| MDR Report Key | 6406440 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-03-15 |
| Date of Report | 2017-03-14 |
| Date Mfgr Received | 2017-02-14 |
| Date Added to Maude | 2017-03-15 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | 2017-03-15 |
| Model Number | 00-1300-4001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 6 MO |
| 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 | 2017-03-15 |