MAUDE Adverse Event Report: ALPHATEC SPINE, INC. ANTERIOR CERVICAL PLATE ASSEMBLY, 2-LEVEL, 032 MM (TI-6AI-4V ELI, NITINOL); SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Model Number	71002-032
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual examination of the returned 2-level plate found that the middle blocking slide had become completely detached from the implant.Witness marks along both the anterior and posterior sides of the plate are present and reveal the location of the instrument to plate during contouring/bending.The plate contains a witness mark on the posterior side directly behind the location of the detached blocking slide and witness marks at both graft windows on the anterior side.The combination of these witness marks confirms the plate bending instrument was positioned inconsistent with ifu requirements while contouring/bending the plate.
Event or Problem Description
While attempting to bend the plate, the middle blocking slide broke/detached from the implant.There were no patient complications.Another plate was selected, bent and implanted without issue.

• Brand Name: ANTERIOR CERVICAL PLATE ASSEMBLY, 2-LEVEL, 032 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: 7446576
• Report Number: 2027467-2018-00024
• Device Sequence Number: 1510386
• Product Code: KWQ
• UDI-Device Identifier: 00844856067004
• UDI-Public: (01)00844856067004
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 04/13/2018

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: 71002-032
• Device Catalogue Number: 71002-032
• Device Lot Number: 708956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2018
• Initial Report FDA Received Date: 04/20/2018
• 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