MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-03-27 for XPRESS MINIMALLY INVASIVE PEDICLE SCREW SYSTEM T073-1000 manufactured by X-spine Systems, Inc..
[140129331]
The complainant requested to return a serious of broken instruments for replacement. The complainant was unable to provide details regarding the incidents. There were no known patient complications associated with the malfunctions. The following mdrs are related to the receipt of this complaint. 3005031160-2019-00013, 3005031160-2019-00014, 3005031160-2019-00015, 3005031160-2019-00016, 3005031160-2019-00017, 3005031160-2019-00018. The rotating rod inserter had worn laser markings and surface scratches, indicating that the instrument was used repeatedly. One of the prongs at the distal end of the instrument was bent outwards and the other was broken and not present. A dhr review was performed and the instrument met all require specifications prior to being made available for distribution on 7/15/2016. The prongs at the distal tip of a rotating rod inserter may become damaged if the instrument were moved laterally while the attached rod was engaged with a screw extension and pedicle screw construct. Lateral movement while engaged with a screw extension and pedicle screw concentrates applied force to the interface between the rotating rod inserter and rod, which may result in the prongs of the inserter becoming misshaped and broken. The rotating rod inserter was inspected and determined to not be in functional condition and was removed from distributable inventory.
Patient Sequence No: 1, Text Type: N, H10
[140129332]
The complainant requested to return a serious of broken instruments for replacement. The complainant was unable to provide details regarding the incidents. There were no known patient complications associated with the malfunctions. The following mdrs are related to the receipt of this complaint. 3005031160-2019-00013, 3005031160-2019-00014, 3005031160-2019-00015, 3005031160-2019-00016, 3005031160-2019-00017, 3005031160-2019-00018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005031160-2019-00018 |
| MDR Report Key | 8457353 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-03-27 |
| Date of Report | 2019-03-27 |
| Date Mfgr Received | 2019-02-25 |
| Device Manufacturer Date | 2016-07-15 |
| Date Added to Maude | 2019-03-27 |
| 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 PEDICLE SCREW SYSTEM |
| Generic Name | PEDICLE SCREW SPINAL SYSTEM |
| Product Code | HTC |
| Date Received | 2019-03-27 |
| Returned To Mfg | 2019-03-06 |
| Model Number | T073-1000 |
| Lot Number | XS157167A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-03-27 |