MAUDE Adverse Event Report: X-SPINE SYSTEMS, INC. AXLE INTERSPINOUS FUSION SYSTEM; PLIERS ALL-IN-ONE INSERTER/COMPRESSOR, ASSEMBLY

Model Number X060-1520

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The complainant reported that an axle all in one inserter broke during insertion of an implant.A second inserter was available, and the procedure was completed.There were no known patient complications.Visual assessment of the instrument identified that a subassembly part was sheared off which would prevent the inserter from functioning as intended.The fracture appeared to start on the inside corner of the tip where there is a sharp corner and potential stress riser.A dhr review was performed, and there were no manufacturing anomalies identified.The device met all required specifications prior to being released to distributable inventory.

Event Description

The complainant reported that an axle all in one inserter broke during insertion of an implant.A second inserter was available, and the procedure was completed.There were no known patient complications.

• Brand Name: AXLE INTERSPINOUS FUSION SYSTEM
• Type of Device: PLIERS ALL-IN-ONE INSERTER/COMPRESSOR, ASSEMBLY
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• Manufacturer (Section G): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• Manufacturer Contact: casey ming ; 664 cruiser lane; belgrade, MT 59714 ; 4063880480
• MDR Report Key: 8010522
• MDR Text Key: 125290772
• Report Number: 3005031160-2018-00031
• Device Sequence Number: 1
• Product Code: HTC
• UDI-Device Identifier: M697X06015201
• UDI-Public: M697X06015201
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: X060-1520
• Device Lot Number: 584601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Date Manufacturer Received: 10/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other