MAUDE Adverse Event Report: ALPHATEC SPINE, INC. INVICTUS; CROSS CONNECTOR INSERTER

Model Number 16021

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/13/2021

Event Type  Injury  

Manufacturer Narrative

A review of the device history records found no manufacturing, processing or design related irregularities.The instrument was found to be properly manufactured and released in accordance with the device master record.Instrument (16021) was used to supplement a final driver (16022).The 16021 universal cross connector inserter is not designed for the input loads of the final driver sequence.

Event Description

The torque handle did not unlock the cross connector so the inserter was used but it broke inside the cross connector.No injury to the patient but a piece of the inserter driver was retained in the patient.

• Brand Name: INVICTUS
• Type of Device: CROSS CONNECTOR INSERTER
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer Contact: brian beireis ; 1950 camino vida roble; carlsbad, CA 92008 ; 7604946739
• MDR Report Key: 11822134
• MDR Text Key: 250813907
• Report Number: 2027467-2021-00024
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00190376284637
• UDI-Public: (01)00190376284637(10)8693301
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 16021
• Device Catalogue Number: 16021
• Device Lot Number: 8693301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Initial Date Manufacturer Received: 04/14/2021
• Initial Date FDA Received: 05/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2021
• 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