MAUDE Adverse Event Report: ALPHATEC SPINE INC ANTERIOR CERVICAL PLATE ASSEMBLY, 1-LEVEL, 022 MM (TI-6AI-4V ELI, NITINOL); SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Model Number	71001-022
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation of the trestle luxe plate is not possible.Although the plate was missing one of its locking mechanisms, the surgeon elected to implant it.The 1-level plate remains positioned within the patients c5-c6 cervical vertebrae.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.
Event or Problem Description
During the surgery, when inserting the screw, the blocking slide came off the plate.The bone condition of the patient was not bad, only the plate was implanted at the doctor's discretion.No health injury of the patient is confirmed.

• Brand Name: ANTERIOR CERVICAL PLATE ASSEMBLY, 1-LEVEL, 022 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: 6237032
• Report Number: 2027467-2016-00112
• Device Sequence Number: 865909
• Product Code: KWQ
• UDI-Device Identifier: 00844856066939
• UDI-Public: 00844856066939
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K102820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: 71001-022
• Device Catalogue Number: 71001-022
• Device Lot Number: 681015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2016
• Initial Report FDA Received Date: 01/10/2017
• 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