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 5.5/6.0 SPINE SYSTEM 00-1003-6001 manufactured by Orthopediatrics Corp..
[53995751]
Surgeon stated he was certain that the dissociation occurred due to the rod not being fully seated, and the driver not being able to overcome the force of the 6. 0mm cocr rod. Surgeon further stated that when he performed the revision surgery on the patient, he observed that the rod was not fully seated. Upon utilizing the reduction tower to fully seat the rod into the pedicle screw, he observed that the rod did reduce further. He then final tightened the set screw using the torque limiting driver handle.
Patient Sequence No: 1, Text Type: N, H10
[53995752]
Set screw disassociated from polyaxial screw causing rod to disengage from polyaxial screw. Surgeon discovered at 6-week follow-up visit with patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006460162-2016-00002 |
| MDR Report Key | 5930748 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-09-06 |
| Date of Report | 2016-08-09 |
| Date Mfgr Received | 2016-03-04 |
| 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 5.5/6.0 SPINE SYSTEM |
| Generic Name | PEDICLE SCREW SPINAL SYSTEM |
| Product Code | OSH |
| Date Received | 2016-09-06 |
| Catalog Number | 00-1003-6001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2016-09-06 |