MAUDE Adverse Event Report: ALPHATEC SPINE, INC. ANTERIOR CERVICAL PLATE ASSEMBLY, 2-LEVEL, 034 MM (TI-6AI-4V ELI, NITINOL); SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Model Number	71002-034
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 4/2/2018 - additional information provided by the sale rep."100% positive the blocking slide did not stay in the patient.Detached section discarded by physician.The plate was installed at the c5-c7.The c6 vertebrae is without a screw.Not sure if additional contour added to the plate prior to implanting (via a plate bender)".An evaluation of the trestle luxe plate is not possible at this time.The implant remains fastened within the patients cervical vertebrae.Upon the receipt of additional information and/or the return of the implant a follow up report will be submitted.
Event or Problem Description
The surgeon grasped a plate with plate holder and as he was trying it in patient, one of the locking slides popped off.Surgeon installed the plate without a locking mechanism at that position, leaving the hole empty (c6).

• Brand Name: ANTERIOR CERVICAL PLATE ASSEMBLY, 2-LEVEL, 034 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: 7454600
• Report Number: 2027467-2018-00021
• Device Sequence Number: 1146792
• Product Code: KWQ
• UDI-Device Identifier: 00844856067011
• UDI-Public: (01)00844856067011
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K102820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/30/2018

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: 71002-034
• Device Catalogue Number: 71002-034
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2018
• Initial Report FDA Received Date: 04/24/2018
• 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: Other
• Patient Age: 62 YR