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 Consequences Or Impact To Patient (2199)
Date of Event	03/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No evaluation possible at this time.The implants have not been returned nor has the identifying lot number(s) been provided.The additional plate which was installed without a locking mechanism, remains fastened within the patients cervical vertebrae.Upon the receipt of additional information and/or the product in question, a follow-up report will be submitted.
Event or Problem Description
The gold piece in the center of both plates popped off after bending each of them to achieve additional lordosis.An additional plate was also bent to fit the patient.The gold piece popped off this one as well, but the surgeon elected to install the plate without a locking mechanism.The event caused no patient harm.

• 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: 8544492
• Report Number: 2027467-2019-00016
• Device Sequence Number: 19422703
• Product Code: KWQ
• UDI-Device Identifier: 00844856067011
• UDI-Public: (01)00844856067011
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 03/26/2019

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: 71002-034
• Device Catalogue Number: 71002-034
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2019
• Initial Report FDA Received Date: 04/24/2019
• 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
• Patient Age: 42 YR