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

Model Number 71540-16

Device Problems Device Slipped (1584); Material Protrusion/Extrusion (2979)

Patient Problem No Code Available (3191)

Event Date 02/05/2020

Event Type  Injury  

Manufacturer Narrative

No evaluation possible.The implant has not been returned for evaluation nor has the identifying lot number been provided.Upon the receipt of additional information and/or the product in question, a follow-up report will be submitted.

Event Description

Two month post-op images revealed a trestle luxe screw had backed out of position.Revision surgery was conducted (b)(6) 2020 to remove and replace only the protruding anchor.The trestle luxe plating system was originally implanted on (b)(6) 2019 during 3-level acdf (anterior cervical discectomy & fusion) case.

• 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: 9745414
• MDR Text Key: 180638425
• Report Number: 2027467-2020-00014
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 00844856067905
• UDI-Public: (01)00844856067905
• 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: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71540-16
• Device Catalogue Number: 71540-16
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• 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: 76 YR