MAUDE Adverse Event Report: ALPHATEC SPINE INC TRESTLE LUXE ANTERIOR CERVICAL PLATING SYSTEM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Model Number 71002-034

Device Problems Detachment of Device or Device Component (2907); Material Protrusion/Extrusion (2979)

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

Event Date 07/14/2020

Event Type  Injury  

Manufacturer Narrative

No evaluation possible.The explanted trestle luxe plate has not been returned.

Event Description

Revision surgery was conducted on (b)(6) 2020 to remove and replace a 2-level trestle luxe plate.The locking mechanism became detached which allowed the screw to protrude.The trestle luxe anterior cervical plating system was initially implanted on (b)(6) 2020.

• Brand Name: TRESTLE LUXE ANTERIOR CERVICAL PLATING SYSTEM
• Type of Device: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• 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: 10385413
• MDR Text Key: 202221041
• Report Number: 2027467-2020-00034
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 00844856067011
• UDI-Public: (01)00844856067011
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102820
• 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: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71002-034
• Device Catalogue Number: 71002-034
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 73 YR