MAUDE Adverse Event Report: ALPHATEC SPINE, INC. ANTERIOR CERVICAL PLATE ASSEMBLY, 1-LEVEL, 020 MM (TI-6AI-4V ELI, NITINOL); SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Model Number	71001-020
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No evaluation possible at this time.The implant has not been returned for evaluation.Upon the receipt of additional information and/or the product in question, a follow-up report will be submitted.
Event or Problem Description
During the surgery, the plate was coming off the bone as the surgeon was attempting to insert the screws.In the process, the locking mechanism got bent and became none functional.

• Brand Name: ANTERIOR CERVICAL PLATE ASSEMBLY, 1-LEVEL, 020 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: 7582196
• Report Number: 2027467-2018-00035
• Device Sequence Number: 1317925
• Product Code: KWQ
• UDI-Device Identifier: 00844856066922
• UDI-Public: (01)00844856066922(10)710746
• Combination Product (Y/N): N
• 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): 05/16/2018

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: 71001-020
• Device Catalogue Number: 71001-020
• Device Lot Number: 710746
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2018
• Initial Report FDA Received Date: 06/08/2018
• 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: 59 YR