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 Known Impact Or Consequence To Patient (2692)
Date of Event	08/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review if the device history records revealed no manufacturing or processing related irregularities.The trestle luxe 2-level plate was found to be properly manufactured and released in accordance with design specifications.Visual examination of the supplied photo found that the middle blocking slide had become completely detached from the implant.Product evaluation cannot be conducted.The implant has 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
While inserting the screws, the gold tab broke off.

• 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: 8992776
• Report Number: 2027467-2019-00043
• Device Sequence Number: 11358825
• Product Code: KWQ
• UDI-Device Identifier: 00844856067004
• UDI-Public: (01)00844856067004(10)713389
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/15/2019

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: Health Professional
• Device Model Number: 71002-032
• Device Catalogue Number: 71002-032
• Device Lot Number: 713389
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2019
• Initial Report FDA Received Date: 09/11/2019
• 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