MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-20 for XPRESS MINIMALLY INVASIVE PEDICLE SCREW SYSTEM X010-0167 NA manufactured by X-spine Systems, Inc..
[128283370]
The complainant reported difficulties reducing a rod into a pedicle screw. The surgeon was unable to use the persuader or the pistol grip reducer. The surgeon was able to reduce the rod using a rod fork. The rod fork was damaged while reducing the rod. There were no known patient complications. The complaint instruments were not returned for complaint assessment. The complainant provided photos of the instruments. The procedure required posterior instrumentation form t9 to l2. Rod contouring for multi-level instrumentation must be performed so that the apex of a bent rod is not in the locking zone of a pedicle screw. The technique guide instructs the end user to verify that the area around the screw to be free of bony protrusions to ensure full engagement of instruments to the pedicle screw. Additionally, the stg instructs that if unable to reduce, consider additional rod contouring, screw relocation or in situ fusion. Dhr reviews for the persuader and rod fork could not be performed, because the lot number was not provided to the company. The dhr for the persuader was reviewed, and there were not manufacturing anomalies. The persuader met all of the required specifications prior to releasing to distributable inventory.
Patient Sequence No: 1, Text Type: N, H10
[128283371]
The complainant reported difficulties reducing a rod into a pedicle screw. The surgeon was unable to use the persuader or the pistol grip reducer. The surgeon was able to reduce the rod using a rod fork. The rod fork was damaged while reducing the rod. There were no known patient complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005031160-2018-00034 |
| MDR Report Key | 8092201 |
| Date Received | 2018-11-20 |
| Date of Report | 2018-11-20 |
| Date of Event | 2018-10-25 |
| Date Mfgr Received | 2018-10-26 |
| Date Added to Maude | 2018-11-20 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. CASEY MING |
| Manufacturer Street | 664 CRUISER LANE |
| Manufacturer City | BELGRADE MT 59714 |
| Manufacturer Country | US |
| Manufacturer Postal | 59714 |
| Manufacturer Phone | 4063880480 |
| Manufacturer G1 | X-SPINE SYSTEMS, INC. |
| Manufacturer Street | 664 CRUISER LANE |
| Manufacturer City | BELGRADE MT 59714 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 59714 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | XPRESS MINIMALLY INVASIVE PEDICLE SCREW SYSTEM |
| Generic Name | PEDICLE SCREW SPINAL SYSTEM |
| Product Code | HXE |
| Date Received | 2018-11-20 |
| Model Number | X010-0167 |
| Catalog Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | X-SPINE SYSTEMS, INC. |
| Manufacturer Address | 664 CRUISER LANE BELGRADE MT 59714 US 59714 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-11-20 |