MAUDE Adverse Event Report: ALPHATEC SPINE INC ANTERIOR CERVICAL PLATE ASSEMBLY, 4-LEVEL, 064 MM (TI-6AI-4V ELI, NITINOL); SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Model Number	71004-064
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records revealed no manufacturing, processing or design related irregularities.The trestle luxe plate 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
While inserting a 4-level trestle luxe plate one of the self-tapping screws passed completely thru the plate.The plate was removed and replaced with a new 3-level plate at which time the rescue screw also passed completely thru this newly implanted plate.The rescue screw was removed from the patient while the 3-level trestle luxe plate remains secured within the patient's cervical spine.Removal and replacement of the implants caused a 30-40 minute delay in the case.

• Brand Name: ANTERIOR CERVICAL PLATE ASSEMBLY, 4-LEVEL, 064 MM (TI-6AI-4V ELI, NITINOL)
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 6401290
• Report Number: 2027467-2017-00009
• Device Sequence Number: 36289
• Product Code: KWQ
• UDI-Device Identifier: 00844856067189
• UDI-Public: 00844856067189
• Combination Product (Y/N): N
• PMA/510(K) Number: K102820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/08/2017

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: 71004-064
• Device Catalogue Number: 71004-064
• Device Lot Number: 654975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2017
• Initial Report FDA Received Date: 03/13/2017
• 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: Other
• Patient Age: 77 YR