MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-09-07 for RESPONSE 5.5/6.0 SPINE SYSTEM 00-1003-4001 manufactured by Orthopediatrics Corp..
[54140287]
Set screw disassociated from polyaxial screw causing rod to disengage from polyaxial screw. Surgeon discovered at 6-week follow-up visit with patient. 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 intended to assure the rod is fully seated into the pedicle screw, he observed that the rod did reduce further. He then final tightened the set screw using the toque limiting driver handle. Reduction tower instruments are provided to specifically provide additional mechanical advantage to aid surgeon in seating the rod into the bottom of the pedicle screw prior to final tightening of set screw. Surgical technique shows how to visually or via palpitation confirm that set screw is fully seated. Device not returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[54140288]
During a post-op follow-up visit, it was noted on x-ray that one of the 6. 0 cocr rods had dissociated from the pedicle screw. A revision surgery was performed that same day.
Patient Sequence No: 1, Text Type: D, B5
[109975015]
(b)(4). Recall number: 3006460162-04-11-2017-001-c.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006460162-2016-00003 |
| MDR Report Key | 5934477 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-09-07 |
| Date of Report | 2017-11-13 |
| Date of Event | 2016-08-02 |
| Date Mfgr Received | 2016-08-02 |
| Date Added to Maude | 2016-09-07 |
| 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 | BIOMEDICAL ENGINEER |
| 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 |
| 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, PRODUCT CODE:OSH |
| Product Code | OSH |
| Date Received | 2016-09-07 |
| Catalog Number | 00-1003-4001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2016-09-07 |