MAUDE Adverse Event Report: ALPHATEC SPINE INC XENON LUMBAR SPINAL FIXATION SYSTEM; HXB

Model Number 22SPT10

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/27/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation of the returned lenke curved probe found the instrument had broken approximately 35mm from the distal tip.The 35mm location is the transition point where the 6.35mm diameter shaft tapers down to the distal tip.This location contains the smallest diameter on the instrument and is subject to the most stress during use.Bone probes are designed to locate the proper pathway and length of the screw which is to be implanted.When used as intended the instrument would not come in contact with the amount of force required to fracture and/or deform the tip in this manner.Additionally, the sales rep indicated the surgeon applied downward force while inserting.

Event Description

Surgeon was inserting the probe into pedicle with some downward force and it snapped.

• Brand Name: XENON LUMBAR SPINAL FIXATION SYSTEM
• Type of Device: HXB
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad, ca
• Manufacturer Contact: richard younger ; 5818 el camino real; carlsbad, ca ; 4949286
• MDR Report Key: 9745731
• MDR Text Key: 191680410
• Report Number: 2027467-2020-00012
• Device Sequence Number: 1
• Product Code: HXB
• UDI-Device Identifier: 00840967190112
• UDI-Public: (01)00840967190112(10)US365T
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 22SPT10
• Device Catalogue Number: 22SPT10
• Device Lot Number: US365T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2020
• Initial Date Manufacturer Received: 01/29/2020
• Initial Date FDA Received: 02/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other