MAUDE Adverse Event Report: ALPHATEC SPINE INC ANTERIOR CERVICAL PLATE ASSEMBLY, 3-LEVEL, 054 MM (TI-6AI-4V ELI, NITINOL); SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Model Number 71003-054

Device Problems Device Slipped (1584); Device Operates Differently Than Expected (2913); Device Dislodged or Dislocated (2923)

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

Event Date 04/26/2017

Event Type  malfunction  

Manufacturer Narrative

An evaluation of the trestle luxe screws is not possible at this time.The implants have not been removed from the patient nor has the identifying lot number(s) been provided.Upon the receipt of additional information and/or the return of the implant(s) a follow up report will be submitted.

Event Description

Screw back out 6 weeks postop.Obvious subsidence at c7 superior endplate.Unclear why locking mechanism failed to prevent screw back out.The trestle luxe anterior cervical plating system was originally implanted on (b)(6) 2017.

• Brand Name: ANTERIOR CERVICAL PLATE ASSEMBLY, 3-LEVEL, 054 MM (TI-6AI-4V ELI, NITINOL)
• Type of Device: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• Manufacturer Contact: vernon trimble ; 5818 el camino real; carlsbad, CA 92008 ; 7604946648
• MDR Report Key: 6584572
• MDR Text Key: 76026760
• Report Number: 2027467-2017-00039
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 00844856067110
• UDI-Public: 00844856067110
• Combination Product (y/n): N
• PMA/PMN Number: K102820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 71003-054
• Device Catalogue Number: 71003-054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/26/2017
• 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): Other
• Patient Age: 58 YR