MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-04-01 for XPRESS MINIMALLY INVASIVE PEDICEL SCREW SYSTEM T073-1000 manufactured by X-spine Systems, Inc..
[140616434]
The complainant reported that while inserting a rod, the distal tip of an inserter broke. The surgeon was able to successfully finish the surgery. There were no known patient complications. The instrument has not been received for complaint investigation. Pictures of the device depicted one of the distal hooks of the inserter broken from the instrument. A dhr review was performed. The instrument met all required specifications prior to being released to distributable inventory on 06/20/2016. A lateral force applied to the inserter while placing a rod into a pedicle screw may have caused the damage to the inserter. Application of lateral force to the inserter concentrates force to the interface between the inserter and rod.
Patient Sequence No: 1, Text Type: N, H10
[140616435]
The complainant reported that while inserting a rod, the distal tip of an inserter broke. The surgeon was able to successfully finish the surgery. There was no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005031160-2019-00019 |
| MDR Report Key | 8471542 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-04-01 |
| Date of Report | 2019-04-01 |
| Date of Event | 2019-03-02 |
| Date Mfgr Received | 2019-03-04 |
| Device Manufacturer Date | 2016-06-20 |
| Date Added to Maude | 2019-04-01 |
| 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 | 3 |
| Brand Name | XPRESS MINIMALLY INVASIVE PEDICEL SCREW SYSTEM |
| Generic Name | PEDICLE SCREW SPINAL SYSTEM |
| Product Code | HTC |
| Date Received | 2019-04-01 |
| Model Number | T073-1000 |
| Lot Number | XS157167A |
| 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 | 2019-04-01 |