MAUDE Adverse Event Report: ALPHATEC SPINE INC 4.0 MM VARIABLE ANGLE, SELF-DRILLING HEXALOBE SCREW, 16 MM (TI-6AI-4V ELI); SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Model Number	71240-16
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information provided by the sales rep revealed the surgeon has recently changed his technique and started using shorter plates and inserting screws at a higher angulations, an angle that is much greater than what the trestle luxe plate affords.He says he's been trying to get compression with his plate and screw construct with this recent change of technique for better fusions.This type of issue has only been seen post-op with corpectomies the few times this has happened.The rep believes this might be a result of increased load being placed on the top screws because of the limited points of fixation the surgeon is working with.The surgeon has consistently used the trestle luxe plating system since 2014.He is familiar with the suggested angulations provided within the surgical technique.Review of the device history records revealed no manufacturing, processing or design related irregularities.The trestle luxe construct was found to be properly manufactured and released in accordance with the device master record.Previous engineering investigation determined that this type of occurrence is the results of over angulation of the anchoring plate screw.Both the surgical technique (lit-84315) and instructions for use (ins-048) state; the surgeon must take great care to properly position bone screw holes when using the variable drill guide and self-centering awl.Excessively converging hole patterns may prohibit proper seating of the bone screws.Hole patterns angled beyond 9° may prohibit proper seating.
Event or Problem Description
Post-op x-rays taken (b)(6) 2017 revealed both screws at the c4 had completely passed thru the plate.Revision surgery was conducted on (b)(6) 2017 in which the trestle luxe system was removed and replaced with a competitor's product the trestle luxe anterior plating system was originally implanted on (b)(6) 2017 during a cervical corpectomy procedure.

• Brand Name: 4.0 MM VARIABLE ANGLE, SELF-DRILLING HEXALOBE SCREW, 16 MM (TI-6AI-4V ELI)
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 6567094
• Report Number: 2027467-2017-00027
• Device Sequence Number: 981560
• Product Code: KWQ
• UDI-Device Identifier: 00844856067349
• UDI-Public: 00844856067349
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K102820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/18/2017

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
• Operator of Device: Physician
• Device Model Number: 71240-16
• Device Catalogue Number: 71240-16
• Device Lot Number: 7964602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2017
• Initial Report FDA Received Date: 05/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization