MAUDE Adverse Event Report: ALPHATEC SPINE, INC. INVICTUS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 17170;17182

Device Problem Separation Failure (2547)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/28/2023

Event Type  malfunction  

Manufacturer Narrative

The device did not return for evaluation.No photographs were provided.The identifying lot number was not provided; therefore, a review of the device history record could not be conducted.Based on the information provided, the root cause could not be determined.

Event Description

It was reported a tower, closed top and tower pusher became cold welded together during a procedure.A metal cutting burr was used to separate them in order to fit a screwdriver down to remove/re-position a screw.There were no patient symptoms or complications reported as result of this event.The surgery was completed successfully.

• Brand Name: INVICTUS
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer (Section G): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer Contact: wes channell ; 1950 camino vida roble; carlsbad, CA 92008 ; 9014283693
• MDR Report Key: 18022017
• MDR Text Key: 326740583
• Report Number: 2027467-2023-00070
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00190376268873
• UDI-Public: (01)00190376268835;(01)00190376268873
• 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: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 17170;17182
• Device Catalogue Number: 17170;17182
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 52 YR
• Patient Sex: Male