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 Known Impact Or Consequence To Patient (2692)
Date of Event	11/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No evaluation possible at this time.The implants have not been returned.Upon the receipt of additional information and/or the product in question, a follow-up report will be submitted.
Event or Problem Description
During a revision case, the surgeon placed all screws into plate.One of the screws went through the plate causing removal of the entire construct.The event caused the surgery to be delayed approximately 1.5 to 2 hours.
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.Visual inspection found posterior damage to one of the thru holes where the screw passed completely thru the plate.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.

• 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: 8120883
• Report Number: 2027467-2018-00086
• Device Sequence Number: 18895281
• Product Code: KWQ
• UDI-Device Identifier: 00844856067189
• UDI-Public: (01)00844856067189(10)711401
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K102820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2018

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: Health Professional
• Device Model Number: 71004-064
• Device Catalogue Number: 71004-064
• Device Lot Number: 711401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2018
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 11/09/2018
• Initial Report FDA Received Date: 11/30/2018
• Supplement Report FDA Received Date: 12/13/2018
• 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
• Patient Age: 46 YR